Injections That Could Ease Your Joint Pain Cleveland Clinic

If youre one of the 30 million adults in the United States who live with joint pain, you know its often debilitating. It cankeep you from staying active and even make daily chores seem impossible. What you might not know is that your doctor can treat you with more than pills or surgery.

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Depending on the severity of your pain, injections can be another option for easing your joint pain andget you moving again, sayssports and medical orthopaedist Jason Genin, DO.

In many cases, we use these injections to try to reduce inflammation and pain in your joints, Dr. Genin says. With some treatments, you often can experience fewer symptoms for several months.

There are several injectable options to help treat knee pain. The injections range from corticosteroids, which have been around for decades, to newer cellular therapies like platelet-rich plasma (PRP), he says.

Your physician will decide which one is best based on your individual needs, says sports and medical orthopaedist Dominic King, DO.

Not every injection is right for every patient, Dr. King explains. We take a lot of time to understand your specific issues and create an injectable plan that works with your entire knee care path. This can include weight loss, exercise, stretching, activity modification, anti-inflammatory medications, as well as injection therapy.

Traditional injections, such as corticosteroids (cortisone), can be effective particularly in the late stages of arthritis, as a way to get past a sudden increase in pain and delay the need for surgery.

Hyaluronic acid (HA) injections often are used when corticosteroid injections dont work. But they usually are approved only for use in the knee.

In some instances, doctors consider HA injections first if you dont have obvious signs of inflammation. HA also is a better option if you have diabetes, as corticosteroids can raise blood sugar levels.

Also known as gel injections, HA injections are chemically similar to your natural joint fluid.

When you have osteoarthritis, joint fluid becomes watery. So, this injection helps to restore the fluids natural properties and works as a lubricant and a shock absorber.

HA is a cushion or a buffer against inflammatory cells in the joint, Dr. Genin says. In some cases, it can stimulate the knee to start producing more natural HA. Some physicians also believe that HA helps reduce pain by coating nerve endings within the joint.

One treatment, which may consist of between one and three injections, usually offers symptom relief for four to five months, but sometimes up to one year. However, pain and stiffness will return. Most insurance companies only approve one HA injection every six months.

Platelet-rich plasma (PRP) injectionsare a newer alternative to treat osteoarthritis joint pain. Cells from the patients own blood are processed in a centrifuge to remove red blood cells and most white blood cells, concentrating the platelets. A growing body of evidence has shown that PRP can be as effective or more effective than anti-inflammatory medications or cortisone, particularly in the early stages of arthritis, Dr. Genin adds.

Side effects include a very low risk of infection and pain at the injection site. You also must stop taking oral anti-inflammatory medications for a short amount of time if you get a PRP injection, Dr. Genin says.

Often, many of these injections are effective in reducing or stopping your joint pain, but its important to remember that they may not keep the pain from returning, Dr. King notes. In fact, theyre most effective when used with other therapies. And we consider surgical options only if other treatment options have failed.

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Injections That Could Ease Your Joint Pain Cleveland Clinic

Precautions After PRP Injections: What to Do and What to Avoid

PRP injections are being used for a growing number of orthopedic injuries and conditions. What is PRP? What are the different types of PRP? Are there precautions after PRP injections that should be followed? Lets dig in.

PRP stands for platelet-rich plasma. This is a concentration of the patients own blood platelets in their serum. Blood is drawn from a peripheral site such as the arm or hand and then spun down in a centrifuge concentrating the platelets. Platelets contain growth factors and chemical mediators which can reduce inflammation, pain, improve blood flow and turbocharge the natural healing process. Current indications for PRP include patellar, hamstring and Achilles tendon injuries, golfers elbow, and mild knee osteoarthritis (1).

Did you know that there are three different types of PRP? Yes, and which one is used is critical to your clinical improvement.

The PRP is actually red in color as it contains both red and white blood cells. This was the first type of PRP available and is produced by older, less advanced centrifuges. A centrifuge is a small tabletop machine that spins the blood which allows for separation and concentration of the blood. Red PRP is typically concentrated to lower levels.

This PRP is actually amber in color and contains few white and red blood cells. It is typically concentrated to lower levels and causes less tissue reaction and swelling.

This PRP is also amber in color and contains few white and red blood cells. It is concentrated to a higher level which is not possible at most clinics as they use bedside centrifuges. At Centeno-Schultz Clinic we understand the importance of having different PRP concentrations to treat different conditions. We have a state of the art laboratory with stem cell scientists that can super concentrate PRP to ensure for your best clinical outcome. Our current publication demonstrates that higher concentrations of PRP are useful for tendon injuries (2).

To better understand PRP and how it functions please click on the video below.

Despite what many websites and clinics recommend, ice should not be used after PRP injections. Inflammation is an important part of the healing process. Ice reduces inflammation and swelling and therefore may compromise the healing process (3). Ice also prompts the blood vessels to get smaller thereby restricting blood flow. Blood flow is critical to healing. One of the precautions after PRP injections is to avoid ice. To learn more about the ligament healing after PRP or stem cell injections please click on the video below.

Rest and healing are important after PRP injections. It is important that the injected PRP be given the opportunity to heal the affected area. In order of this to happen the PRP must be given the opportunity to set in place. Platelets release important growth factors and proteins that promote tissue regeneration and healing. It takes up to seven days for the growth factors to be released from the platelets (4) Exercise may displace and move the PRP from injected site thereby compromising healing and outcome. For example, if your kneecap tendon was injected, running or heavy weightlifting immediately after the injection may result in the PRP being pushed out of the tendon. Rest for the first two weeks followed by the gradual return to normal exercise is ideal closely monitoring pain and swelling. One of the precautions after PRP Injection is to avoid vigorous exercise and weightlifting and rest which will allow the PRP work and promote healing.

Alcohol can negatively affect platelet function. Specifically, it can decrease its platelet activation and aggregation (5) and response to other proteins and enzymes. (6). Alcohol can also affect stem cell numbers and function which may compromise healing. The effectiveness of PRP is based on your own bodys ability to heal. Commit yourself to healthy foods, good sleep and no alcohol for maximal healing.One of the precautions after PRP injections is to avoid alcohol.

PRP is a concentration of the patients own blood platelets in their serum. Platelets contain growth factors and mediators that reduce inflammation, improve blood flow and turbocharge the natural healing process. There are different types of PRP which are available in different concentrations. Precautions after PRP injections include avoiding the use of ice, limiting exercise and alcohol. For the best clinical outcome use heat, rest and adopt a healthy lifestyle.

1. Hussain N, Johal H, Bhandari M. An evidence-based evaluation on the use of platelet rich plasma in orthopedics a review of the literature. SICOT J. 2017;3:57. doi:10.1051/sicotj/2017036

2.Berger DR, Centeno CJ, Steinmetz NJ. Platelet lysates from aged donors promote human tenocyte proliferation and migration in a concentration-dependent manner.Bone Joint Res. 2019;8(1):3240. Published 2019 Feb 2. doi:10.1302/2046-3758.81.BJR-2018-0164.R1

3.Hsu SL, Liang R, Woo SL. Functional tissue engineering of ligament healing.Sports Med Arthrosc Rehabil Ther Technol. 2010;2:12. Published 2010 May 21. doi:10.1186/1758-2555-2-12

4.Golebiewska EM, Poole AW. Platelet secretion: From haemostasis to wound healing and beyond.Blood Rev. 2015;29(3):153162. doi:10.1016/j.blre.2014.10.003

5. Mukamal KJ, Massaro JM, Ault KA, et al. Alcohol consumption and platelet activation and aggregation among women and men: the Framingham Offspring Study. Alcohol Clin Exp Res.2005;29(10):19061912.DOI:10.1097/01.alc.0000183011.86768.61.

6. Olas B, Wachowicz B, Saluk-Juszczak J, Zieliski T. Effect of resveratrol, a natural polyphenolic compound, on platelet activation induced by endotoxin or thrombin. Thromb Res.2002;107(34):141145.DOI:10.1016/s0049-3848(02)00273-6.

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Precautions After PRP Injections: What to Do and What to Avoid

Treatment of diabetic foot ulcer in France | CEOR

Introduction

Chronic non-healing ulcer is a major health problem and its prevalence in the world ranges from 1.9 to 13.1%.1,2 The incidence of chronic ulcers is expected to increase as the population ages and the risk factors for atherosclerotic occlusion such as smoking, obesity and diabetes are increasing. One of the main causes of non-healing ulcer is diabetes. Diabetic foot ulcer (DFU) is diagnosed in 1218% of patients with type 2 diabetes and in 0.62% of patients with type 1 diabetes.3 In addition, 70% of these patients are diagnosed with peripheral neuropathy.4,5 Diabetic chronic wounds lead to pain, discomfort, infection, consultations, dressings, hospitalizations, sequelae, sick leave, and poor quality of life. Individuals with diabetic foot ulcers are susceptible to infection and the healing process is complicated by diabetic neuropathy leading to chronic non-healing ulcers. Consequently, an estimated 12% of individuals with diabetic foot ulcer require lower extremity amputation.3,8,9

Moreover, chronic ulcers also represent a substantial financial burden for the patient and the healthcare system.6,7 The Eurodiale study analysed the direct and indirect annual costs in several European countries (in 14 European centres including Spain, France, the UK, Czech Republic, Germany, Denmark, Sweden and Italy) with a total of 821 patients with DFU. The mean annual cost per patient was 10,091, hospitalization being the most relevant direct cost.10 In the UK, the mean NHS cost of wound care over 12 months was estimated at 7800 per DFU (of which 13% was attributable to amputations), ranging from 2140 to 8800 per healed and unhealed DFU, respectively, and 16,900 per amputated wound.11 The main element (around 20%) of total spending is complications related to DFU.12 In the US, DFU accounted for 83% and 96% of all major and minor amputations related to foot ulcers, respectively, and significantly increased cost of care (DFU: $1.38 vs non-DFU: $0.13 billion/year; p <0.001).13 Therefore, it is important to evaluate strategies that can ensure better prevention and management of this type of wound to lower the number of amputations.

The goal of ulcer treatment is to obtain wound closure as expeditiously as possible. Conventional treatment for non-healing ulcers includes wound cleansing, necrotic tissue debridement, prevention, diagnosis, and, if necessary, treatment of infection, mechanical off-loading, management of blood glucose levels and local ulcer care with dressing application.3,14 Therapeutic procedures to manage DFU are fundamentally based on an adequate covering of the wound, early treatment of the infection, and relief of pressure, with a probability of healing being close to 60% in 1 year. Despite treatment, many chronic ulcers fail to heal or persist for months/years and/or recur after healing, requiring additional advanced wound care therapies for adequate healing. At 31 months follow up, diabetic foot ulcers have around a 40% of recurrence and 12.3% were not healed at the end of the follow-up period.1517 Moreover, at 3 years there is evidence of a 10% to 20% rate of amputations.15,18,19,44

It has been demonstrated that plasma growth factor (PGF) such as platelet derived growth factor (PDGF) significantly shortens treatment duration and leads to healing in approximately 80% of wounds.2024 Many authors2024 found that platelet release has improved healing rates if compared with standard remedies. On the other hand, other studies20,21 found no major difference in healing outcome of leg ulcers, between treatment groups with platelet release and control groups (placebo). An extensive review was performed by Picard et al 2015. They carried out a PubMed and Cochrane search (19782015) including all studies assessing the clinical effect of platelet-rich plasma (PRP) on the healing of diabetic chronic wounds. The screening retrieved 7555 articles and 12 studies were included. Of six randomized studies included, five found significant benefits for the use of PRP on diabetic chronic foot ulcers. The authors concluded that 87.5% of controlled studies found a significant benefit for the adjunction of PRP to treat chronic diabetic wounds. As PRP may be beneficial, they suggest using it on diabetic ulcers which remain unhealed after standard treatment.25 The most recent meta-analyses and review articles have highlighted the therapeutic potential of PRP in chronic wounds with demonstrated benefits in several clinical outcomes, notably complete wound closure, wound surface reduction, scar reduction, and a lowering of incidence of infections.2634

The clinical results of PRP effectiveness in the treatment of DFU are promising considering, however, that the costs associated with treating DFUs with PRP are presumably higher than using standard therapy. Therefore, the implementation of this therapeutic approach in health systems should be based on its cost-effectiveness. Only a few studies have directly dealt with the relationship between the costs and the results of PRP versus standard care and, in addition, no economic evaluations in parallel with clinical studies have been reported. Two studies prior to 2014 found PRP treatment being cost-effective or even dominant compared with usual care.22,35,36 Recently, Linertov et al found that, in a 5-year time horizon, PRP treatment for DFU could be considered a cost-effective or even a cost-saving alternative in Spanish healthcare settings, depending on the method of obtaining the PRP (commercial kit versus manual method) and, to a large extent, on the price of the kit used. As a consequence, these authors called for future studies on the effectiveness and costs of specific devices or methods to be used as inputs for more specific cost-effectiveness models.37 The objective of this study is to close the gap through a cost-effectiveness analysis, with a 1-year time horizon, of a specific PRP preparation procedure for the treatment of DFU versus standard of care accounting for cost using a micro-costing approach. In order to collect detailed data on resource use, material costs and professional time spent on care, our analysis was conducted alongside a clinical study (Le Creusot study, France).38 This paper provides more specific evidence and insights for clinical and managerial decision making exploiting a French setting.

A randomized controlled trial to evaluate the safety and efficacy of autologous platelet-rich plasma (PRP) gel for stimulating wound healing in chronic deep diabetic foot ulcers (3 A stage according to UT classification) was performed at the Fondation Htel-Dieu hospital in Le Creusot, France. N=86 diabetic patients were randomized either to best standard of care (SoC) alone or PRP treatment combined with SoC. Good standard of care was used when appropriate and included debridement, infection control, comorbidities management and off-loading. The two arms were comparable at baseline for age, presence of a neuropathy, antiaggregant treatment, and depth and surface of wounds.38

In PRP treatment, gel is obtained from patients blood by getting a platelet-rich, leukocyte-poor plasma using Regenkit (RegenLab, Switzerland). The commercial kit consists of 3 tubes (2 BCT and 1 ATS) that are used to produce a PRP gel.

This is an outpatient clinical protocol: after a 2-week run-in period, if no reduction of wound surface >20% was observed, patients were randomized (PRP gel application or control SoC treatment). Patients were treated for 6 weeks maximum (less in case of wound closure). PRP gel arm patients could receive more than one gel application upon investigator decision. Primary efficacy endpoint for wound closure was measured at 6 weeks. Efficacy was also evaluated at follow-up visits at 9 and 12 weeks.

For the PRP arm, only protective compress change was done at home once weekly, while for the control group the dressing change was performed at home once daily.

Forty-six patients were randomized to the PRP gel treatment and 40 to the SoC alone arm. All patients were neuropathic, with deep ulcers mostly located on toe and metatarsal, but also heel and plantar vault. Chronic wound duration was on average more than 6 months.

In terms of results observed at 6 weeks after initiation of treatment, PRP arm shows a complete wound closure in 56.5% of patients versus 20.0% in control group, with a statistically significant difference (p 0.001). Similarly, PRP arm reaches 77.3% wound closure at 12 weeks versus 35.7% for SoC control group. During the study, data on resource use and costs were collected. In particular, the authors picked for both arms material usage, professional time spent on care and costs for each activity.

The cost-effectiveness analysis was performed using a Markov model, with a hypothetical cohort of patients with chronic DFU (duration of >3 weeks) with high orthopaedic risk and with ulcers graded 3A (UT classification), meaning deep ulcers down to the bone, including tunnelling and perforating wounds.

Using a decision-analytical model, we defined a structure and within it could insert evidence from this specific clinical study's outcomes (Le Creusot study) as well as from the literature to generalize the results. The advantage of using Markov model is that it is flexible, particularly adapted for modelling chronic diseases spreading over months or years, and deals with ongoing risks and events that might happen more than once over time (recurrence).

The first step was to define DFUs in terms of mutually exclusive states, including all relevant health outcomes, with movement between these states based on transition probabilities. In this study, the Markov model contained six possible health states (2 temporary states, 3 standard states, 1 absorbing state): (1) DFU (first) complete treatment; (2) persistent DFU; (3) completely healed DFU; (4) amputation; (5); post-amputation; and (6) death from any cause and because of surgery (see Figure 1). At the beginning of the model, patients with DFUs would receive the first treatment according to one of the following strategies: PRP combined with best SoC or Soc alone. Hypothetical patients started in state 1 and moved into predefined health states. Each clinical state had an associated cost and effectiveness estimate. Hypothetical patients accumulated costs and QALYs associated with the time spent in each clinical state during the simulated 3-month period. The cycle length was 1 week and the time horizon was 1 year.

Figure 1 Markov model of diabetic foot ulcer. States are identical for usual and PRP care.

In the first state, patients receive their first complete treatment. The first state is a temporary state, therefore patients receive value of cost and utilities for the first treatment and then go with a 100% probability to the second state. In state 2 (persistent DFU), they receive the weekly care. For PRP treatment, there is a certain probability of needing a new complete treatment that is more costly than the weekly care. We modelled the necessity of some patients having more than one complete treatment using a transient event rather than a state. Therefore, we used transition rewards so that a one-time cost was associated with a patient having a second treatment. Although the need of a new treatment is not a state itself, and it has no effect on state transition, it may have costs (and/or disutilities) associated with it. For traditional care, this possibility is not allowed since the dressing change is performed daily until the wound is healed.

In state 2, for PRP arm, the home nurse opens the dressing and checks the cleanliness of the primary dressing (according to Le Creusot study protocol, this is performed once a week in the absence of complications). If the dressing is clean, the nurse will operate the simple replacement of the secondary dressing. Otherwise, a second complete treatment is planned. State 2, for usual treatment arm, draws the complex dressing (dressing change) performed by a home nurse every day who carries out the cleaning and dressing procedure 5 days per week.

In state 3, patients receive costs and utility of a complete healing of their ulcer. As scientific evidence shows, there is some probability that diabetic patients can have a new occurrence, thus they can move from the state complete wound disclosure, through relapse, to the necessity of new medications. State 6 is the absorbing state and collects individuals dying from any cause (life table) and because of surgery. Results are reported in terms of incremental cost-effectiveness ratio (ICER).

All costs associated with health states and transition costs in the Markov model were measured in euros for 2019, as presented in Table 1. Costs were estimated through a micro-costing approach alongside the resources used in Le Creusot study. These costs are from the perspective of the French healthcare system.

Table 1 Data Used in the Model: Costs

For the cost of dressings, we have made a few estimations to get the average price of a simple dressing (PRP group) and a complex dressing (SoC group). Simple dressing made use of Jelonet, Adaptic, Grassolind plus secondary dressing as serum. Complex dressing, depending on wound characteristics, made use of different families of products. From Le Creusot study we have a rate of utilization of 70% of hydrocellular dressing (Mepilex, Ialuset, Urgotull), 20% on superabsorbant hydrocellular dressing (Cutimed, Wilsabord, Sorbact) and 10% using Urgostart. In Appendix Table 1, we summarize the main parameters used. The details of the calculations on the materials used are included in the Excel file Couts Materiels Hopital.

In state 1, PRP cost is due to: the use of regenkit BCT-1 (X2) and ATS (X1) + cleaning procedure + the medication + nurse time. The cost of comparator is due to the cost of complex dressing + cleaning procedure + nurse time (state 1: DFU complete treatment: PRP arm: 186; comparator: 12.6). In state 2, PRP cost of 7.3 is due to the repair of the medication + nurse time. The cost of comparator is due to the cost of complex dressing + cleaning procedure + nurse time multiplied 5 times per week (state 2: persistent DFU (PRP: 7.3; comparator: 63).

Quality of life assessments for six possible health states (see model description) were based on general health status profiles, which are less sensitive than illness-specific scales but allowed us to analyse and compare results outside the context of a certain disease. A variety of generic preference-based measures have been developed; the most used questionnaires include the EuroQol EQ-5D, the Short Form 6D (SF-6D) and the Health Utilities Index (HUI). Once completed, the questionnaires generate a score using an algorithm based on values that have been obtained from a sample of the general public.40 The values are the health-related quality of life (HRQoL) and measure the utility from living in a specific health state. Health states assume HRQoL values between 0 (dead) and 1 (perfect health); negative values are possible when the health status is considered worse than death. QALYs are assessed by combining the weights calculated for health states alongside the time spent in those health states. QALYs represent the number of years lived in perfect health. The advantage of their use is the possibility to compare results among pathologies and among willingness to pay thresholds for health outcomes.

In this analysis, quality of life assessments for the six possible health states were based on the generic EuroQol instrument and obtained from a previous published study, as presented in Table 2.41 Redekop et al used a time trade-off method to estimate the utility weights associated with a range of health states related to DFUs and their complications. This source was also used previously to provide the quality-of-life estimates for a cost-effectiveness analysis of a negative pressure device for the treatment of DFUs. QALYs were calculated by multiplying the quality-of-life utility weight for one health state by the number of years staying in that state.

Table 2 Data Used in the Model: Effectiveness (at 3 Months)

Probabilities of healing were informed by the proportion of ulcers completely healed at the 12-week time point (Le Creusot study data), 77.3% for PRP care and 35.1% for usual care. Whereas Le Creusot study showed strong results in favor of PRP, in our cost-effectiveness analysis we decided to use a conservative approach. The model parameters were from a recent meta-analysis based on five existing clinical trials; the healing success was 58.33% for PRP and 50.31% for usual care28 (see Table 3).

Table 3 Data Used in the Model: Probability of Healing (at 3 Months)

In Le Creusot study, a total of 27 patients had one injection, 17 had two injections and 2 patients had 3 PRP applications. On average, patients received 1.46 PRP treatments. Therefore, we modelled a conservative probability of 0.5 per cycle to receive a second complete treatment (from Le Creusot study, the probability of having a second complete treatment is 0.2).

To generalize the model, the risk of amputation and relapse were included. Amputation is a temporary state leading to the post-amputation state. The probability of amputation was taken from the Moulik study18 and adjusted according to the model cycles (1 week). The new occurrence probability was taken from the Eurodiale study.44

All annual and three-month probabilities were transformed to weekly probabilities by the formula proposed by Briggs:39

where tp1 is the weekly transition probability we wish to estimate and tpt is the overall probability over time, t.

Deterministic sensitivity analysis has been conducted to assess the impact of the uncertainty of the parameters used in the model on the results. Deterministic sensitivity analyses are useful to deal with different uncertainties, whereby: (i) model uncertainty means every model is a simplification of the reality, (ii) parameter uncertainty is an estimation of costs and effectiveness, and (iii) heterogeneity is the individual variability between patients. Therefore, the sensitivity analyses have been run for the most important parameters of the model (Tables 13). Deterministic sensitivity analysis (DSA) has been run for every minmax scenario of any parameters. In detail, one-way DSA and tornado analysis have been run for every parameter where a min and max scenario is reported.

Probabilistic sensitivity analysis (PSA) was performed through a Monte Carlo simulation, performing 10,000 cases, to assess the uncertainty around the ICER and the probability of the PRP therapy to be cost-effective at different willingness to pay thresholds. A probability distribution was assigned at each model input parameter to describe the different values the parameter can have with different probabilities. The effectiveness and probabilities have been modelled with beta distributions; costs were represented as Gamma distributions as recommended in literature.45 For the parameters cited in literature where it was not estimated standard error, it was assumed a general standard error of 25% of the mean value.39

All analyses were perfomed using TreeAge Pro 2021.

In the base case scenario PRP treatment results in cost savings. The average cost per QALY is around 188 for comparator and 181 for PRP, respectively. The ICER of PRP treatment is 613/QALY, which, being lower than zero, indicates the dominance of the PRP therapy.

In order to know how each parameter influences the results, a one-way sensitivity analysis was performed for the main parameters. The tornado analysis shows the collection of one-way sensitivity analyses for the main parameters (see Figure 2). The DSA results are consistent with the base case scenario. However, for some parameters the PRP treatment is not cost-saving but having a positive ICER can be cost-effective according to the willingness to pay thresholds used.

Figure 2 Tornado analysis.

The most sensitive parameters are the PRP arm probability of needing a new complete treatment and the number of weekly medications carried out for both. The analysis shows that the main difference in costs is due to the daily nurse visits and dressing changes for the comparator therapy, while for PRP therapy we have only one visit per week. The PRP therapy cost is higher in the first week (186) due to the expense for medical devices and nurse time, but it decreases at few euros over the following weeks because only 50% of patients per week need a new complete medication. Therefore, the PRP branch needs less nurse time and a reduced use of materials resulting in a cost saving in respect of the standard of care (SoC) alone. Initially, PRP treatment is more costly but at each cycle the cumulative costs become lower than for usual care and from week 7 the comparator become the most expensive. This trend is due mainly to less frequency of medications for PRP and to a better healing probability (Figure 3).

Figure 3 Cumulative cost per week of the two therapies.

Changing the PRP arm's probability of needing a new complete treatment from 0.5 to 0.7 leads PRP strategy to be no longer cost-saving, with an ICER of 732/QALY. Including a lowest number of SoC weekly medications (from 5 to 3) leads to a 622/QALY, while increasing PRP weekly medication (from 1 to 4) has an ICER of 732/QALY. Considering common thresholds of around 20/30,000, PRP is a cost-effective option.

Other sensitive parameters that lead PRP therapy to be cost-effective and not cost-saving are the cost of the kit used and the total cost of the complete procedure.

The probabilistic sensitivity analysis was performed through a Monte Carlo simulation considering 10,000 scenarios (or cases). All the parameters and variables of the model vary according to the assigned distribution. Figure 4 shows the corresponding acceptability curve with the WTP thresholds. For every WTP threshold, the percentage of cases in favor of PRP or HA is shown, where the percentage of cost-effective iterations is derived from a probabilistic sensitivity analysis performed through the Monte Carlo simulation. For example, at 10,000/QALY there is a 77% probability for PRP treatment to be cost-effective.

Figure 4 Cost-effectiveness acceptability curve of PRP vs SoC under various WTP thresholds.

The present study evaluates the cost-effectiveness of PRP treatment compared with usual management of DFU patients in patients with chronic DFU (duration of >3 weeks) with high orthopaedic risk and ulcers graded 3A (UT classification). This work was conducted along with a clinical study (Le Creusot study) allowing a micro-costing approach in the assessment of resource utilization. Conservative data on effectiveness obtained from a recent meta-analysis were considered (the healing success was 58.33% for PRP and 50.31% for usual care).28 Under these assumptions, the PRP therapy resulted in cost-savings in the base case scenario.

The number of weekly medications for both treatments and the PRP arm probability of needing a new complete treatment influence the results because the PRP, after the first complete medication, needs only one intervention per week in comparison to five for usual care. PRP has higher cost for the complete medication but, in the absence of complications (nurse checks once weekly), only the change of secondary dressing is needed. In the absence of healing signs, the physician can schedule a second PRP application. The probability used in the model for a second PRP complete treatment is 50% weekly. Therefore, PRP has the potential to involve lower consumption of resources (both nurse time and materials). As shown in sensitivity analysis, considering three medications per week (instead of five) for usual care, PRP is no longer the cost-saving therapy but with a 622/QALY is cost-effective (ICER inferior to the threshold of 30,000/QALY). Our results confirm the findings of identified economic evaluations3537 which found the PRP treatment being cost-effective or even dominant compared with usual care. The three works before 2014 have limited methodological quality and do not provide sufficient details of the evaluated procedures. A recent study from a Spanish setting found that, in a 5-year time horizon, PRP treatment for DFU could be considered a cost-effective or even a cost-saving alternative. However, there are few economic evaluations probably because of the scarcity of robust clinical trials and for the wide heterogeneity of the population enrolled in the studies.

This work is not free from limitations. It used cost data specific to the French setting because it is rooted in Le Creusot study. It helps to give more details regarding the PRP vs SoC procedure and allows a micro-costing approach, but it can be less generalizable to other contexts. For example, even if the tornado analysis showed consistent results, the number of PRP complete treatments may influence the outcome of the model and thus calls for further analysis. Moreover, the results need to be interpreted in light of a limited level of evidence complicated by heterogeneity in the characteristics of the patients treated and adding to these factors also the procedures used for PRP/usual care therapies such as, for example, the number of medications and the type of materials used. Therefore, more high-quality randomized controlled trials, possibly with longer term follow up, are required.

In conclusion, considering limitations, the PRP treatment for DFU could be considered a cost-effective or even a cost-saving alternative in the French setting.

This study does not contain human/animal test subjects.

The paper is the advancement of a previous working paper published on the website of Department of Management, University C Foscari Venice: Salvatore Russo & Stefano Landi, 2020. Cost-effectiveness analysis for the treatment of diabetic foot ulcer in France: PRP vs standard of care, Working Paper n.4/2020, August 2020, ISSN:2239-2734. This research was supported by University Ca Foscari Venezia through a grant provided by Regenlab SA to SL. Salvatore Russo and Stefano Landi are co-first authors for this study.

All authors made a significant contribution to the work reported. In detail, all authors worked on the conception, study design, and interpretation. SC worked on acquisition of data, SL and SR on execution and analysis. All authors took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

SC formerly worked for Regen Lab as external consultant. The authors report no other conflicts of interest in this work.

1. Rayner R, Carville K, Keaton J, et al. Leg ulcers: atypical presentations and associated co-morbidities. Wound Pract Res. 2009;17(4):168185.

2. Agale SV. Chronic leg ulcers: epidemiology, aetiopathogenesis, and management. Ulcers. 2013;Article ID 413604:9.

3. Greer N, Foman N, Dorrian J, et al. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. VAESP Project #09-009; 2012.

4. Abbott CA, Carrington AL, Ashe H, et al. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community based patient cohort. Diabet Med. 2002;19:377384. doi:10.1046/j.1464-5491.2002.00698.x

5. Abbott CA, Vileikyte L, Williamson S, et al. Multicenter study of the incidence of and predictive risk factors for diabetic neuropathic foot ulceration. Diabetes Care. 1998;21:1071. doi:10.2337/diacare.21.7.1071

6. Siersma V, Thorsen H, Holstein PE, et al. Importance of factors determining the low health-related quality of life in people presenting with a diabetic foot ulcer: the Eurodiale study. Diabet Med. 2013;30:1382. doi:10.1111/dme.12254

7. Hopkins RB, Burke N, Harlock J, et al. Economic burden of illness associated with diabetic foot ulcers in Canada. BMC Health Serv Res. 2015;15:13. doi:10.1186/s12913-015-0687-5

8. Buckley CM, OFarrell A, Canavan RJ, et al. Trends in the incidence of lower extremity amputations in people with and without diabetes over a five-year period in the Republic of Ireland. PLoS One. 2012;7:e41492. doi:10.1371/journal.pone.0041492

9. Brem H, Tomic-Canic M. Cellular and molecular basis of wound healing in diabetes. J Clin Invest. 2007;117:12191222. doi:10.1172/JCI32169

10. Prompers L, Huijberts M, Schaper N, et al. Resource utilisation and costs associated with the treatment of diabetic foot ulcers. Prospective data from the Eurodiale Study. Diabetologia. 2008;51:18261834. doi:10.1007/s00125-008-1089-6

11. Guest JF, Fuller GW, Vowden P. Diabetic foot ulcer management in clinical practice in the UK: costs and outcomes. Int Wound J. 2018;15(1):4352. doi:10.1111/iwj.12816

12. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217228. doi:10.1001/jama.293.2.217

13. Hicks CW, Selvarajah S, Mathioudakis N, et al. Burden of infected diabetic foot ulcers on hospital admissions and costs. Ann Vasc Surg. 2016;33:149158. doi:10.1016/j.avsg.2015.11.025

14. Anderson I. Aetiology, assessment and management of leg ulcers. Wound Essent. 2006;1:2036.

15. Winkley K, Stahl D, Chalder T, Edmonds ME, Ismail K. Risk factors associated with adverse outcomes in a population based prospective cohort study of people with their first diabetic foot ulcer. J Diabetes Complications. 2007;21:341349. doi:10.1016/j.jdiacomp.2007.09.004

16. Pound N, Chipchase S, Treece K, Game F, Jeffcoate W. Ulcer-free survival following management of foot ulcers in diabetes. Diabet Med. 2005;22:13061309. doi:10.1111/j.1464-5491.2005.01640.x

17. Peters EJG, Armstrong DG, Lavery LA. Risk factors for recurrent diabetic foot ulcers: site matters. Diabetes Care. 2007;30:20772079. doi:10.2337/dc07-0445

18. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26(2):491494. doi:10.2337/diacare.26.2.491

19. Martinez-Zapata MJ, Mart-Carvajal AJ, Sol I, et al. Autologous platelet rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2012;10:Art. No.: CD006899. doi:10.1002/14651858.CD006899.pub2

20. Saad Setta H, Elshahat A, Elsherbiny K, Massoud K, Safe I. Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study. Int Wound J. 2011;8(3):307312. doi:10.1111/j.1742-481X.2011.00797.x

21. OMeara SM, Cullum NA, Majid M, Sheldon TA. Systematic review of antimicrobial agents used for chronic wounds. Br J Surg. 2001;88:421. doi:10.1046/j.1365-2168.2001.01631.x

22. Kantor J, Margolis DJ. Treatment options for diabetic neuropathic foot ulcers: a cost-effectiveness analysis. Dermatol Surg. 2001;27:347351. doi:10.1046/j.1524-4725.2001.00280.x

23. Suthar M, Gupta S, Bukhari S, Ponemone V. Treatment of chronic non-healing ulcers using autologous platelet rich plasma: a case series. J Biomed Sci. 2017;24:16. doi:10.1186/s12929-017-0324-1

24. Senet P, Bon FX, Benbunan M, et al. Randomized trial and local biological effect of autologous platelets used as adjuvant therapy for chronic venous leg ulcers. J Vasc Surg. 2003;38:13421348. doi:10.1016/S0741-5214(03)00908-X

25. Picard F, Hersant B, Bosc R, Meningaud JP. The growing evidence for the use of platelet-rich plasma on diabetic chronic wounds: a review and a proposal for a new standard care. Wound Repair Regen. 2015;23(5):638643. doi:10.1111/wrr.12317

26. Conde-Montero E, de la Cueva Dobao P, Martnez Gonzlez JM. Platelet-rich plasma for the treatment of chronic wounds: evidence to date. Chronic Wound Care Manag Res. 2017;4:107120. doi:10.2147/CWCMR.S118655

27. Hirase T, Ruff E, Surani S, Ratnani I. Topical application of platelet-rich plasma for diabetic foot ulcers: a systematic review. World J Diabetes. 2018;9(10):172179. doi:10.4239/wjd.v9.i10.172

28. Del Pino-Sedeo T, Trujillo-Martn MM, Andia I, et al. Platelet-rich plasma for the treatment of diabetic foot ulcers: a meta-analysis. Wound Repair Regen. 2019;27(2):170182. doi:10.1111/wrr.12690

29. Hsieh TS, Chiu WK, Yang TF, Wang HJ, Chen C. A meta-analysis of the evidence for assisted therapy with platelet-rich plasma for atrophic acne scars. Aesthetic Plast Surg. 2019;43(6):16151623. doi:10.1007/s00266-019-01471-w

30. Shen Z, Zheng S, Chen G, et al. Efficacy and safety of platelet-rich plasma in treating cutaneous ulceration: a meta-analysis of randomized controlled trials. J Cosmet Dermatol. 2019;18(2):495507. doi:10.1111/jocd.12853

31. Ding H, Fu XL, Miao WW, Mao XC, Zhan MQ, Chen HL. Efficacy of autologous platelet-rich gel for diabetic foot wound healing: a meta-analysis of 15 randomized controlled trials. Adv Wound Care (New Rochelle). 2019;8(5):195207. doi:10.1089/wound.2018.0861

32. Li Y, Gao Y, Gao Y, et al. Autologous platelet-rich gel treatment for diabetic chronic cutaneous ulcers: a meta-analysis of randomized controlled trials. J Diabetes. 2019;11(5):359369. doi:10.1111/1753-0407.12850

33. Xia Y, Zhao J, Xie J, Lv Y, Cao DS. The efficacy of platelet-rich plasma dressing for chronic nonhealing ulcers: a meta-analysis of 15 randomized controlled trials. Plast Reconstr Surg. 2019;144(6):14631474. doi:10.1097/PRS.0000000000006281

34. Hu Z, Qu S, Zhang J, et al. Efficacy and safety of platelet-rich plasma for patients with diabetic ulcers: a systematic review and meta-analysis. Adv Wound Care (New Rochelle). 2019;8(7):298308. doi:10.1089/wound.2018.0842

35. Dougherty EJ. An evidence-based model comparing the cost-effectiveness of platelet-rich plasma gel to alternative therapies for patients with nonhealing diabetic foot ulcers. Adv Skin Wound Care. 2008;21(12):568575. doi:10.1097/01.ASW.0000323589.27605.71

36. Cobos Campos R, Parraza Diez N, Aizpuru Barandiaran F. Platelet-rich plasma in skin ulcer treatment. Wounds. 2013;25(9):256262.

37. Linertov R, Del Pino-Sedeo T, Prez LG, et al. Cost-effectiveness of platelet-rich plasma for diabetic foot ulcer in Spain [published online ahead of print, 2020 Feb 10]. Int J Low Extrem Wounds. 2020;1534734620903239. doi:10.1177/1534734620903239.

38. Clavel S, Albache N, Labrut H, Robu E, Denizot C. Autologous platelet gel: an help in chronic deep diabetic foot ulcers treatment in 2019 Diabetic Foot Conference Abstracts. J Diabetes Sci Technol. 2020;14(3):601678. doi:10.1177/1932296819897643

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Treatment of diabetic foot ulcer in France | CEOR

Trends Shaping The Future Of Beauty And Cosmetics In 2022

The Global beauty industry is currently valued at $532 billion. However, like every other industry, the global beauty industry is also prone to constant change and growth. The ongoing pandemic also took a massive toll on this industry. This is why you need to understand the ongoing trends that will have a huge impact on the future of beauty and cosmetics in 2022. This will allow us to understand better the direction in which the global beauty industry is moving. Here are the top trends that are expected to dominate the future of beauty and cosmetics.

The ongoing pandemic has taught everyone the importance of hygiene and cleanliness in our everyday lives. The professionals expect this trend to continue in the future, even when the pandemic is finally over. Everyone was looking for hand sanitizer and hand soaps during the pandemic. This has slowly encouraged beauty brands to enter this arena, and they have started offering luxurious and beauty-oriented hand soaps and sanitizers.

People will stay loyal to their favorite beauty brands, and professionals expect them to buy hand sanitizers and other hygiene items from their favorite beauty brands. This way, we will see a revolution in the hygiene department.

People love and demand transparency from their favorite brands. We no longer live in an era when people were unaware of the ingredients used in their favorite products. This is why people want to know what they are putting on their skin. This demand has encouraged beauty brands to sign up with third-party labs to offer complete transparency regarding skincare items. This trend will change the future of beauty and cosmetics in 2022.

Transparency will be among the top priorities of different brands. The customers want to know what they are using, and these brands are willing to offer them a detailed report of all the ingredients and chemical formulas used in the products. This will allow the customers to understand whether their product is sustainable and organic.

The ongoing pandemic has forced us to live inside the confines of our homes. This gave us a chance to digitize every aspect of our life. People who were previously unwilling to adopt technology into their lives completely rely on digital technology to continue their daily activities.

This dependence on technology also increased our exposure to blue light. Blue light is known to have damaging effects on the skin. This is where beauty brands jumped in and started working on innovative ingredients to minimize blue lights damaging impact on our skin.

Blue light protection is one of the most anticipated and biggest trends that we will see in the future. The customers want to take care of their skin, and beauty companies are here to help you slow down the process of skin aging. We will see ingredients such as turmeric and algae in our favorite products.

This may sound odd at first. However, hundreds of different beauty companies are constantly trying to transform solid makeup items into liquid makeup. When customers spend a lot of money on beauty products, they expect those products to stay on for a while. We have already seen waterproof mascara and lipstick items in the past. 2022 will be the year where the consumers finally see liquid lipsticks and liquid items expected to stay on the skin throughout the day.

This trend was quite popular even before the pandemic. However, minimalist makeup is expected to make a comeback in the upcoming years. People want to feel beautiful and independent even without the use of makeup accessories. In addition to this, complicated makeup routines also take up a lot of time, and many customers do not have enough time for such routines. This is why we will see our rise in minimalist makeup accessories and routines.

Slow beauty and natural skincare are all the rage right now. Therefore, many people are trying to understand how to make their skin glow up without foreign elements. They want to say goodbye to foreign elements and embrace a healthier way of achieving beautiful skin daily. This is why we will see minimalist makeup practices in the future.

As the entire world slowly shifted towards online video calls and meetings for daily chores, some people were worried about their outlook and face in virtual meetings. A lot of people were worried about how they looked online. This is why skin surgeons and dermatology experts saw an immense boost in the number of people who wanted to learn more about the different cosmetic procedures for facial concerns.

The number of people who investigated different procedures for eye area treatments was higher than ever. This trend is expected to continue down the road, and people will slowly move towards facial treatments and cosmetic surgeries to look better and more beautiful on video calls and virtual chat rooms.

We may not feel it or see it, but our fingers are home to a whole host of bacteria. In addition to this, there are also colonies of viruses that live on our skin. Similarly, an average person touches their hair more than 40 times a day.

We may not see it, but there is an exchange of bacteria and viruses between your hair and fingers. This takes a negative toll on the health of your hair. This is why scientists and professionals have been trying to develop innovative solutions to take care of hair.

2022 may be the year when we finally see antibacterial haircare. Many different beauty companies are already working on creating antibacterial haircare products that are safe for customers, such as cleaning sprays, antibacterial shampoos, and antibacterial moisturizers. These items are expected to fight against any bacteria or virus and offer antimicrobial disinfecting agents that will offer maximum protection for your hair throughout the day.

Another arena that will see a massive improvement in 2022 is the scalp area. People slowly understand the importance of taking care of their scalp. This is why we will see a boost in the number of people who will move towards scalp treatments to reduce hair loss and improve hair health. Platelet-rich Plasma (PRP) injections are becoming more and more common among people.

Another important trend that you can see in the year 2022 is that people will try to move towards organic and plant-based skincare items. Some people are already trying to minimize their impact on the environment. Skincare is the next arena that will see a massive evolution in minimizing the carbon footprint on the environment.

People are trying to move towards plant-based skincare items for multiple reasons. One of the reasons is to minimize the impact on the surrounding environment. Another important reason is that people want to stay away from harsh chemicals and introduce naturally occurring ingredients into their daily skincare routine.

A lot of people are trying to investigate the benefits of using hemp-based or CBD creams. We will see a massive increase in consumers who will try to move towards plant-based skincare items.

In the past, people used to spend a lot of money on getting different hairstyles and artificially augmenting their natural hair. However, we will see a decrease in this trend as people have started to believe in low maintenance power.

Similarly, people are also quite happy to embrace themselves as they are. This will change the

future of beauty and cosmetics in 2022. We will see more and more people embrace their natural hair and stay away from hair straightening or hair curling activities. In addition to this, customers are also worried about hair loss and hair damage. This is why we will see many people embrace air-drying and the natural texture of their hair. They will try to stay away from chemicals and intense heat for hair straightening activities.

People will slowly try to move towards low-maintenance and natural hair care routines. They will also try to find organic and natural shampoos for the daily hair care routine. Therefore, we will see people embracing their natural texture and natural hair more often.

Here are the top 10 statistics that you must know to understand the future of beauty and cosmetics in 2022.

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Trends Shaping The Future Of Beauty And Cosmetics In 2022

Knee and Hip Arthritis: Self-Assessment and Management – Baptist Health South Florida

Could the pain you are feeling be arthritis? Francisco J. Garcia, physician assistant at the arthritis clinic at Miami Orthopedics & Sports Medicine Institute, answered this commonly asked question when he addressed the self-assessment and management of knee and hip arthritis at a recent virtual community health discussion.

The symptoms of knee and hip arthritis can impede your ability to exercise, participate in social activities and go on vacation, and this decrease in activity can lead to muscle weakness, obesity, falls and, ultimately, depression, Mr. Garcia said.

Arthritis may be classified as osteoarthritis, inflammatory arthritis or posttraumatic arthritis, Mr. Garcia explained.

Osteoarthritis involves the degeneration of hyaline cartilage the hard, slippery tissue that covers the ends of bones where they form a joint. The condition is usually caused by the wear and tear over time. The joints most commonly affected include the knees, hips, neck, lumbar spine and hands, Mr. Garcia says. Osteoarthritis is genetic- and age-related, with early signs manifesting around age 50.

Inflammatory arthritis is triggered by an autoimmune disease that attacks the lining of the joint capsule, most commonly in the wrists, hands, fingers, toes and knees. The inflammatory process can eventually destroy cartilage and bone within the joint, Mr. Garcia explains. The most common types are rheumatoid arthritis, gout, lupus and psoriatic arthritis. These diseases have a genetic component, can occur at any age and affect women more than men.

Post-traumatic arthritis is caused by a physical injury that damages the cartilage and/or bone and changes the mechanics of the joint, making it wear out more quickly. The injury can be from sports or a vehicle accident, fall or military injury.

Since the knees and hips bear weight, they are among the most common joints affected by arthritis.

Knee Arthritis

Arthritis in the knee occurs when the cushion between the femur and tibia has deteriorated. When self-assessing your knee health, consider these symptoms of knee arthritis:

Hip Arthritis

Arthritis in the hip occurs when the cartilage in the joint gradually wears away and the protective joint space between the bones decreases. In addition to osteoarthritis, inflammatory arthritis and post-traumatic arthritis, this degeneration can be caused by hip dysplasia a genetic condition in which the hip socket does not fully cover the ball portion of the upper thighbone.

When self-assessing your hip health, Mr. Garcia recommends that you consider these symptoms of hip arthritis:

Conservative Treatments

To reduce the effect of arthritis on your quality of life, Mr. Garcia recommends seeing a specialist to evaluate your condition and initiate a non-surgical management plan to reduce your symptoms. Your conservative care plan may include:

Injections can lubricate the joint and reduce pain and inflammation, Mr. Garcia explained. For the knee, a cortisone injection can provide two to three months of relief while a hyaluronic acid injection is effective for three to six months. Injections in the hip give short, mild relief but do not last as long as knee injections.

Surgical Treatments

When conservative treatments fail and pain affects your quality of life, surgical management may be warranted. Partial knee replacements and total knee replacements are performed under spinal anesthesia and sedation. Some patients will stay one night in the hospital while other qualified patients will be discharged home on the same day. Mr. Garcia recommends that all patients attend physical therapy for six to eight weeks to achieve the best outcome.

Patients undergoing hip replacement surgery also may stay one night in the hospital or be discharged the same day. The orthopedic surgeons at Miami Orthopedics & Sports Medicine Institute use the anterior approach, which protects soft tissue from damage, rather than the posterior or lateral approach, which has a longer recovery and increases the risk of dislocation and leg length discrepancy. Patients will be ambulating on the day of surgery and start physical therapy immediately.

For most people, joint replacement surgery is a game changer, providing pain relief, improved mobility and a better quality of life, Mr. Garcia says.

Tags: arthritis, hip arthroscopy, knee pain

Continued here:
Knee and Hip Arthritis: Self-Assessment and Management - Baptist Health South Florida

JAWS and the 2022 Hall of Fame Ballot: Carl Crawford – FanGraphs

The following article is part of Jay Jaffes ongoing look at the candidates on the BBWAA 2022 Hall of Fame ballot. For a detailed introduction to this years ballot, and other candidates in the series, use the tool above; an introduction to JAWS can be found here. For a tentative schedule and a chance to fill out a Hall of Fame ballot for our crowdsourcing project, see here. All WAR figures refer to the Baseball-Reference version unless otherwise indicated.

Content warning: This piece contains details about alleged domestic and gun violence. The content may be difficult to read and emotionally upsetting.

2022 BBWAA Candidate: Carl Crawford

SOURCE: Baseball-Reference

The new millennium hasnt exactly been a banner one for the stolen base. Between soaring home run rates and the influence of analytics on front offices, the tactic has gone out of style, and per-game rates have fallen. As one-run strategies go, teams seem content to wait for a player to knock a ball over a wall rather than manufacture a run. During the first decade of the 2000s, as home runs kept flying, Carl Crawford stood out for his electrifying speed and skill on the basepaths.

In the first eight full seasons of his 15-year career (2002-16), Crawford led the American League in stolen bases four times, finished second once and third twice, stealing at least 46 bases in each of those seasons. He topped an 80% success rate in the first five of those seasons, and led the league in triples three times as well. Crawfords wheels as well as his midrange power and strong defense helped him make four All-Star teams and win a Gold Glove while starring for the Rays first two playoff teams.

Alas, Crawford hit free agency, signed a massive seven-year deal with the Red Sox, and almost immediately went into the decline phase of his career due to injuries. After totaling 35.6 WAR with Tampa Bay from 2002-10, he managed just 3.5 WAR over his final six seasons spent with Boston and the Dodgers while missing substantial time due to Tommy John surgery, plus wrist, finger, oblique, and hamstring woes. He was released by Los Angeles with a year and a half still to go on his contract, and never played again.

Since retiring, Crawford has made grim headlines, including one for a 2020 arrest for domestic assault against his ex-girlfriend, and another for the drowning of a 5-year-old boy and 24-year-old woman during a party at his home and a subsequent lawsuit alleging negligence. If Crawford were a serious candidate for election, on the level of Omar Vizquel, such matters might cost him the support of voters. As it is, they complicate his legacy.

Crawford was born on August 5, 1981 in Houston, Texas, and grew up in the Fifth Ward. His grandfather, Roy Burns, ran a legendary barbecue restaurant, Burns Original BBQ, in Houston, and his father Steve went into the family business. Later, so did Carls brother, Cory, and Crawford used some of his career earnings to help finance the restaurants rebirth.

As a child, the left-handed Crawford pitched and played first base for the Smokey Jasper Park Angels, a Little League team coached by Ray Bourn, whose son Michael yes, Michael Bourn was 16 months younger than Crawford. The younger Bourn played 11 years in the majors (2006-16), won three stolen base titles and made two All-Star teams but was not included on this years Hall of Fame ballot despite being eligible. The team was very good, but due to a lack of money for travel, We didnt even get a chance to play in (the Little League World Series), Crawford recalled in 2014. I mean we beat everybody else. We scrimmaged one of those teams that went and blew em out. The situation led Crawford to help fund the travel of the national title-winning Jackie Robinson West team from Chicago.

At Jefferson Davis High School, Crawford lettered in football, basketball, and baseball. While lore has it that UCLA offered him a basketball scholarship to play point guard, Crawford later debunked that story. He did sign a letter of intent to go to the University of Nebraska on scholarships for football and baseball, but when the Devil Rays chose him in the second round of the 1999 draft (the 52nd pick overall), he soon signed for a $1.245 million bonus.

When he began his career with the Devil Rays Princeton affiliate in the Appalachian League in 1999, Crawford was still just 17 years old and comparatively inexperienced at baseball, given his interests in other sports. Nonetheless, he hit .319/.350/.404 and stole 17 bases in a league where he was 2.7 years younger than the average player, then hit .319/.350/.404 with league-leading totals of 170 hits and 55 steals, not to mention 11 triples, as an 18-year-old in the South Atlantic League. Baseball America placed him 72nd on their Top 100 Prospects list in the spring of 2001 while noting that the Devil Rays rave about Crawfords ability to take instruction and put it to use. His enthusiasm is apparent, and he never seems intimidated [even if] his inexperience sometimes shows.

Despite hitting a more modest .274/.323/.352 with 36 steals at Double-A Orlando in 2001, Crawford moved up to number 59 on BAs list because hed held his own as a 19-year-old. From his prospect capsule:

He has great speed, quick wrists and a good idea of how to hit. His superior work ethic rivals that of any player in the system, and hes considered the Devil Rays most coachable prospect. Crawfords arm is his lone below-average tool. His baseball instincts, such as taking the correct routes on fly balls, should get better with experience. His pitch recognition and ability to work counts need improvement, and his swing could use some refinement.

After spending the first half of the 2002 season at Triple-A Durham, Crawford was called up to make his major league debut. He went 1-for-4 with a two-run single off the Blue Jays Brian Bowles on July 20, 2002, 16 days short of his 21st birthday. On a team that lost 106 games, Crawford hit just .259/.290/.371 for a 77 OPS+ in 278 PA, but his baserunning and defense still boosted his value to 1.0 WAR. His hitting was only slightly better the following year (.281/.309/.362, 81 OPS+), but he did steal an AL-high 55 bases in 65 attempts; between his baserunning, double play avoidance and 11 Defensive Runs Saved, he was worth 2.3 WAR, a respectable showing for an age-21 season.

Crawford broke out in 2004, making his first All-star team, hitting .296/.331/.450 (105 OPS+) with league bests in triples (19) and steals (59), and 4.9 WAR. That began a four-year run during which he hit for a 112 OPS+ (.304/.341/.467) while averaging 14 homers, 15 triples, 53 steals, and 4.5 WAR. He made the AL All-Star team again in 2007, led the league in triples in 05 and 06, and in steals in 06 and 07; from 2005-07, he was successful on 85% of his stolen base attempts. In April 2005, he signed a four-year, $15.25 million extension that included club options for 2009 and 10.

The Devil Rays remained a bad ballclub in this span, losing fewer than 95 games only in 2004. But the times they were a-changin in Tampa Bay. Manager Lou Piniella and general manager Chuck LaMar were replaced by Joe Maddon and Andrew Friedman after the 2005 season, and the Devil Rays became the Rays after 07. With rookie third baseman Evan Longoria joining Crawford, B.J. Upton, and a stable of young pitchers led by James Shields and Matt Garza, the team turned the corner in 2008, winning 97 games and the AL East. Crawford was not at his best, however; between a four-game suspension for his part in a brawl against the Red Sox, a minor hamstring injury, and surgery to repair a subluxation of his right middle finger tendon, he played in just 109 games and hit for an 89 OPS+ with just 25 steals and 2.5 WAR.

Despite not making a single major league plate appearance after August 9 due to injuries, Crawford reclaimed his starting left field job at the outset of the 2008 postseason, and hit .290/.333/.468 as the Rays beat the White Sox and Red Sox before losing to the Phillies in a five-game World Series. His biggest contribution came in Game 4 of the ALCS, when he went 5-for-5 with two doubles and a triple, scoring three runs and driving in two in a 13-4 win. He homered off both Cole Hamels and Joe Blanton in the World Series, albeit both in games that the Rays lost.

The Rays picked up Crawfords options in each of the next two seasons, and he responded with performances that netted him All-Star berths in both years. He hit .305/.364/.452 (116 OPS+) with 15 homers and career highs of 60 steals including an AL record-tying six in one game on May 3 and 5.0 WAR in 2009, and was the MVP of the All-Star Game for his robbery of a potential go-ahead home run by Brad Hawpe.

Crawford topped that with a career year, hitting .307/.356/.495 with highs in slugging percentage, homers (19), OPS+ (135) and WAR (7.0, good for sixth in the league) while stealing 47 bases and boasting a league-high 13 triples. Though his 8 DRS wasnt his best, he did bring home his only Gold Glove that year as well. The Rays won the AL East again, but lost a five-game Division Series to the Rangers; Crawford went just 3-for-21, though two of his hits and his only homer came in Tampa Bays Game 3 win.

That big season carried the 29-year-old Crawford into free agency, where his speed, athleticism, defensive ability, and budding power attracted the attention of the Red Sox, who had missed the playoffs for the first time since 2006. When fellow free agent Jayson Werth signed a seven-year, $126 million deal with the Nationals, Crawford and his agents, Greg Genske and Brian Peter, got a boost. He signed with the Red Sox for seven years and $142 million, choosing them over the Angels, who were reportedly offering the same package. The deal was the games 11th-largest at the time, and the sixth-largest of any free agent to that point, after those of Alex Rodriguez ($275 and $252 million), Mark Teixiera ($180 million), CC Sabathia ($161 million), and Manny Ramirez ($160 million).

Crawfords time in Boston was a disaster. He hit .155/.204/.227 in April 2011, missed a month from mid-June to mid-July due to a hamstring strain, and declined in every phase of his game, hitting just .255/.289/.405 (85 OPS+) with 11 homers and 18 steals his lowest total since his rookie season in 130 games. The Red Sox nonetheless carried the ALs best record into September, but went just 7-20 the rest of the way. Still, they entered the final night of the season at 90-71, tied with the Rays for the AL Wild Card spot, and headed to the ninth inning of their season finale up 3-2 on the lowly Orioles. After striking out the first two batters in the ninth, closer Jonathan Papelbon gave up back-to-back doubles to Chris Davis and Nolan Reimold, tying the game. With pinch-runner Kyle Hudson on second base, Robert Andino lined a ball to left field, where Crawford tried unsuccessfully to make a sliding catch, then threw home too late to prevent the winning run from scoring. It made for an enduring image not just of the teams season, but of the left fielders tenure in Boston.

The Red Sox lost that game, but they werent eliminated until the Rays erased a 7-0 deficit against the Yankees in the eighth and ninth innings, then won in the 12th.

In January, Crawford underwent surgery to repair cartilage in his left wrist. Initially, the Red Sox explained he had begun experiencing soreness during his offseason hitting workouts, but by Opening Day, it emerged that hed dealt with wrist pain for years and had received painkilling injections to manage the problem in 2011. Just as he neared his return in late March, he sprained his left UCL and received an injection of platelet-rich plasma. He didnt make his season debut until July 16, 2012, and it soon became apparent both that his elbow was still a problem and that the Red Sox were going nowhere, so he underwent Tommy John surgery in late August.

On August 25, two days after that surgery, the Red Sox shocked the baseball world by trading Crawford, Josh Beckett, Adrian Gonzalez, Nick Punto, and $258 million cash all but $12 million of what remained on the players respective contracts to the Dodgers for a five-player package.

Crawford was surprised by the trade,and relieved. When he reported to spring training, he spoke of Bostons toxic environment and his inner struggles. I just didnt see a light at the end of the tunnel, he told the Los Angeles Times Dylan Hernandez. It puts you in kind of a depression stage. You just dont see a way out. A year and a half later, he admitted that he hadnt done his research on Boston or spoken to a single player who had played there about his experience.

Crawfords return to action was solid but unspectacular. He hit .283/.329/.407 (107 OPS+) with 15 stolen bases and 1.5 WAR in 116 games, missing just over a month due to a hamstring strain. He came up big in the Division Series against the Braves, going 6-for 17 with three homers in a four-game victory; he hit a three-run shot off Julio Teheran in Game 3, then homered twice of Freddy Garcia in Game 4. Though he collected hits in all six games of the Dodgers NLCS loss to the Cardinals, he scored just twice and drove in one run, that via a solo homer off Joe Kelly in a Game 5 win.

Crawfords 2014 season was his best as a Dodger, not that it was a complete one. The 32-year-old left fielder hit .300/.339/.429 (118 OPS+) with 23 steals in 29 attempts, and 2.4 WAR, but he missed six weeks due to a left ankle sprain. Though he went 5-for-17 against the Cardinals in the Division Series, the Dodgers fell in four games.

From there, the returns diminished. Crawford was the Dodgers Opening Day left fielder in both the 2015 and 16 seasons, but slipped below replacement level and was increasingly unavailable due to injuries. He missed 12 weeks in 2015 due to an oblique strain, and played in just 69 games, finishing with -0.2 WAR, then played in just 30 games, missing time due to a lower back strain. On June 5, a point at which he was a full win below replacement level in just 87 PA, the team designated him for assignment, then released him while still owing him $35 million. Despite the fact that he would have cost just the league minimum, he never played again. The Rays reportedly expressed at least some interest in bringing him back in late June of 2016 when their outfield was depleted by injuries, and he mulled a comeback over the following winter, but that was it for his career.

Crawfords career total of 480 stolen bases ranks only 43rd all-time, but its fourth among those since the year 2000, behind only Juan Pierre (614), Jos Reyes (517), and Ichiro Suzuki (509), with 2022 ballot newcomer Jimmy Rollins (470) fifth, and current candidate Bobby Abreu seventh (347 of his 400). Similarly, Crawfords 81.5% success rate ranks sixth among players with at least 300 stolen base attempts in that span, with Carlos Beltrn first (87.3%, nearly a point higher than his overall 86.4% dating back to 1998) and Rollins (81.7%) fourth. Crawfords total of 83 runs for baserunning and double play avoidance also ranks fourth for the span behind Ichiro (118), Johnny Damon (95, from his career total of 125 dating back to 1995), and Pierre (85).

Alas, all of that is at least somewhat overshadowed not only by the dud that was Crawfords contract but by his post-career legal issues. In 2017, he founded 1501 Certified Entertainment, a music label. Rapper Megan Thee Stallion signed with the label in early 2018 and soon found success, but when she signed a management deal with Jay-Zs label Roc Nation in September 2019, 1501 blocked her from releasing new music. In response, she sued 1501 and Crawford, calling the contract unconscionable and the label purposefully and deceptively vague in paying her; the case is ongoing.

More tragically, on May 16, 2020, two people, 5-year-old Kasen Hersi and 25-year-old Bethany Lartigue, drowned in the backyard swimming pool during a party at his house in Houston. The woman had been staying at Crawfords home while filming music videos; she jumped in to save the boy but neither one survived after being administered CPR. The boys father soon sued Crawford for $1 million for negligence, claiming that he had failed to take reasonable and necessary steps to prevent the boy from having access to the pool. Crawford publicly expressed remorse over the two deaths; the current status of that lawsuit is unknown.

On June 3, 2020, Crawford was arrested in Houston and charged with assault of a family member/impeding breathing, a felony. According to court documents, Crawford showed up at the Houston apartment of his ex-girlfriend, with whom he has a daughter who was one year old at the time, on May 8. The woman alleged that Crawford fired a semi-automatic handgun, threatened her at gunpoint, slammed her head against the wall and squeezed her neck. The emergence of the couples child distracted Crawford long enough for her to escape. Crawford also allegedly fled the scene, but left behind the handgun.

Crawford turned himself in and was freed on $10,000 bond. Via lawyer Rusty Hardin (who previously represented Roger Clemens in allegations related to the Mitchell Report), he denied the charges and his conduct. While further developments in the case were not publicly reported, according to Harris County court records, he was indicted by a grand jury in December 2020, but the case was dismissed the following March when his ex-girlfriend refused to cooperate with the prosecution.

Even without prosecution, such disturbing stuff would likely compromise a serious candidates chances for election to the Hall of Fame, and as it is, the litany makes even appreciating the high points of Crawfords uneven career a complicated matter.

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JAWS and the 2022 Hall of Fame Ballot: Carl Crawford - FanGraphs

Platelet-rich plasma injections: an emerging therapy for …

Abstract

Autologous platelet-rich plasma (PRP) injections have been investigated in recent years as an emerging therapy for various musculoskeletal conditions, including lumbar degenerative disc disease. Although PRP has received increasing attention from medical science experts, comprehensive clinical reports of its efficacy are limited to those treating knee osteoarthritis and epicondylitis. Use of PRP is gaining popularity in the area of degenerative disc disease, but there is a clear need for reliable clinical evidence of its applications and effectiveness. In this article, we review the current literature on PRP therapy and its potential use in the treatment of chronic discogenic low back pain, with a focus on evidence from clinical trials.

Keywords: Platelet-rich plasma (PRP), chronic back pain, discogenic, disc degeneration

Low back pain is one of the major causes of physical disability affecting both older and younger people and can have enormous socioeconomic and health impacts. One of the major causes of low back pain is age-associated intervertebral disc degeneration (1,2), which affects the nervous system around the disc. Stimulation of the nociceptors in the annulus fibrosus causes pain, which is termed discogenic pain (3). Interestingly, degeneration, endplate injury and inflammation can stimulate pain receptors inside the disc, leaving the external disc intact (4). Intervertebral disc degeneration can be described as an active process involving changes in tissue and the cellular microenvironment that eventually lead to structural breakdown and impairment of intervertebral disc function (5).

Reported pathologic features of painful discs include the formation of zones of vascularized granulation tissue with extensive innervation in annular fissures (6). Due to the avascular nature of intervertebral discs and, hence, their limited ability to regenerate, research on the regeneration of intervertebral discs and the various associated treatment methods has increased. Raj et al. [2008] (7) reported that various biochemical changes occur during disc degeneration, including loss of proteoglycan, loss of collagen fibers, increased fibronectin, increased enzymatic activity, increased fragmentation of collagen, proteoglycan and fibronectin, and changes in nutritional pathways. Histologic examination of painful discs has revealed the formation of a zone of vascularized granulation tissue extending from the nucleus pulposus to the outer part of the annulus fibrosus along the edges of the annular fissures, and growth of nerves deep into the annulus fibrosus and nucleus pulposus (8).

Disc degeneration is accompanied by changes in the matrixes of both the nucleus pulposus and the inner annulus fibrosus that are mediated by an inflammatory process (9). Nociceptive stimuli include pro-inflammatory cytokines produced by disc cells [such as interleukin (IL)-1, IL-4, IL-6, IL-8, IL-12, IL-17], interferon-, tumor necrosis factor (TNF)-, downstream signaling molecules such as nitric oxide (NO), leukotrienes, prostaglandin E and by-products of disc cell metabolism such as lactic acid (9). Disc degeneration can also be caused by aging, apoptosis, vascular ingrowth, failure of nutrient supply to disc cells, abnormal mechanical loads or genetic factors (7,10). Rather than simply providing symptomatic relief, it is important to understand the pathophysiology of degenerated discs to determine the most effective treatment of the underlying cause.

As extensively reviewed by Raj et al. (7) and Simon et al. (11), a number of methods are used for the management of discogenic low back pain (). Since it is widely believed that degenerated discs are the source of discogenic pain, treatments mostly focus on surgical procedures such as fusion and total disc replacement. The reliability and effectiveness of these surgical procedures are still debated, as they are reported to only offer pain relief (9). Alternatively, non-invasive methods such as benign neglect, physical therapy or symptom control with medication or injection have been employed to treat discogenic pain. Notably, these treatments do not improve the underlying degenerative condition, although they do resolve its symptoms (12). This clearly indicates the need for new therapies and/or interventions that actually treat the underlying causes of discogenic pain. Accordingly, increased attention has been given to emerging techniques such as growth factor therapy, and biomolecular and cellular treatments.

Current treatment methods for discogenic low back pain

Previously reported in vitro, in vivo and clinical data clearly demonstrate the effectiveness and feasibility of biomolecular and cellular therapies for treating degenerative disc disease (13-15). Direct injection of growth factors into the annulus fibrosus and nucleus pulposus have resulted in clinically-proven improvement (16). Cellular and biomolecular treatments (which are in the clinical trial stage) combined with tissue engineering and annular repair (which are still in the preclinical stages) have been proposed to have great potential for the treatment of degenerative disc disease (17). Regenerative therapies for degenerated discs should focus on stimulating the production of the extracellular matrix or inhibiting the cytokines that upregulate matrix-degrading enzymes, which in turn may prevent loss of disc space height, increased loading on posterior elements and spinal stenosis (18).

PRP is defined as autologous blood with platelet concentrations above the physiological baseline. It is obtained by a centrifugation process which separates the liquid and solid components of blood (19,20). In recent years, PRP injections have gained considerable attention as a treatment method for musculoskeletal conditions due to their safety and ability to potentially enhance soft tissue healing. Tissue regeneration in musculoskeletal conditions is achieved by injecting PRP percutaneously. PRP has been effectively used for the treatment of rotator cuff tears, osteoarthritis of the knee, ulnar collateral ligament tears, lateral epicondylitis, hamstring injuries and Achilles tendinopathy (21). However, there is limited data showing its effectiveness for the treatment of intervertebral disc degeneration and low back pain. This article aims to shed light on the use of PRP for treating discogenic low back pain by reviewing the current clinical evidence in human applications.

PRP is postulated to promote endogenous healing processes; however, the mechanism remains unclear. It is reported that healing occurs after PRP stimulates the recruitment, proliferation and differentiation of cells involved in regeneration via a number of growth factors and proteins released from the platelets (22). Nonetheless, platelets contain antibacterial proteins and are capable of migrating to injury sites (23). The growth factors released by platelets include vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), transforming growth factor (TGF) -1, platelet-derived growth factor (PDGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF)-I, basic fibroblast growth factor (bFGF) and connective tissue growth factor (CTGF), which contribute significantly to tissue proliferation (22,24,25). These growth factors, produced by the concentrated platelets present in PRP, may restore the integrity of the extracellular matrixes of degenerating intervertebral discs (26). A key characteristic of these platelets is that they can release cytokines, chemokines and chemokine receptors and, thus, contribute to the regulation of inflammatory responses and immunological aspects of tissue healing. Platelets also prevent excessive leukocyte recruitment by anti-inflammatory cytokines (27).

How does PRP inhibit disc degeneration? Disc degeneration is a sequential process possibly starting with a circumferential tear in the annulus fibrosus that progresses to a radial tear, herniation, loss of disc height and resorption (28). In skin wound healing, platelets have the ability to bring disrupted cells closer together. Likewise, platelets pull the edges of degenerated disc tears together, leading to healing of cells. However, this is quite challenging due to the avascular nature of discs, which are not highly vascularized like skin (28).

Existing data on PRP and intervertebral disc degeneration include in vitro studies, in vivo studies, preclinical animal studies and human clinical trials. There is a large amount of evidence for the efficacy of the injection of growth factors for the treatment of intervertebral disc degeneration in animal models (14,29-33). PRP has also proven its efficacy in vivo in the improvement of disc height and disc hydration (17), which has enabled the technology to be used in human clinical trials. The remainder of this review will focus on clinical studies and human applications.

Clinical evidence for PRP treatment of discogenic low back pain in humans has been reported since 2011 (34). Since then, a limited number of clinical studies have demonstrated the effectiveness of PRP therapy (). In 2011, Akeda et al. (34) conducted a preliminary clinical trial demonstrating the safety and efficacy of intradiscal injection of autologous PRP as a biological therapy for degenerative disc disease. The study was performed on six patients who suffered chronic low back pain for more than three months. Degenerated discs were confirmed by magnetic resonance imaging (MRI) and standardized provocative discography. At six months follow-up, patients showed a significant decrease in mean pain score and no adverse events were reported post-treatment.

Summary of clinical evidence on platelet rich plasma for the treatment of discogenic low back pain

Bodor et al. [2014] studied 35 patients who were given 47 disc injections of PRP in the lumbar and thoracic spine (28). Two-thirds of the patients showed positive outcomes. The authors also presented a detailed case series of five patients with discogenic back pain treated with PRP injections. The follow-up period ranged from ten days to 10 months, in which patients exhibited substantial improvements in pain that enabled them to return to normal physical activities. Despite two patients having vasovagal episodes, there were no complications or side effects related to this treatment.

In 2016, Levi et al. published data from a prospective clinical trial on 22 patients examining the effect of intradiscal PRP injection on discogenic back pain (35). No complications or serious side effects were reported. Back pain was measured using a visual analogue scale (VAS) and Oswestry Disability Index (ODI). After a 6-month follow-up period, 47% of patients reported at least a 50% improvement in pain and a 30% improvement in their ODI score. The authors speculate that the time frame required for the treatment to take effect, possible adverse effects from the anesthetics and antibiotics used during the procedure, and the PRP preparation method used, account for the lack of a significant positive outcome in this study. In another study by Navani and Hames [2015], six patients were given a single injection of 1.53 mL of autologous PRP (36). At a 24-week follow-up, patients reported a 50% decrease in pain according to the verbal pain scale (VPS), with no adverse effects reported.

In 2016, Hussein and Hussein performed a clinical trial on 104 patients with chronic low back pain (37). Unlike the studies mentioned earlier in this section, platelet leucocyte-rich plasma (PLRP) was used instead of PRP, owing to the phagocytic nature of leucocytes. Injections were carried out weekly for 6 weeks. The method was proven to be a safe and effective method for relieving chronic low back pain, with a success rate of 71.2% reported by the authors. No adverse effects or complications were reported other than short-term pain at the injection site.

The first double-blind randomized controlled trial (RCT) of intradiscal PRP therapy was performed by Tuakli-Wosornu et al. in 2016 on 47 participants with chronic lumbar discogenic pain (38). Participants with a history of chronic axial low back pain were recruited and were randomly allocated to treatment or control groups at a 2:1 ratio, respectively. At an 8-week follow-up, outcomes were measured by Functional Rating Index (FRI), Numeric Rating Scale (NRS)-best pain, the Short Form (SF)-36, and modified North American Spine Society (NASS) satisfaction scores. The study found statistically significant improvements in the treatment group, and the effects of PRP were sustained for a period of at least 1 year according to FRI scores. No complications were reported.

In a pilot study performed on ten patients in 2016 by Bhatia and Chopra, PRP injections were shown to improve pain (39). Patients suffering from chronic prolapsed intervertebral discs were given single 5 mL injections of autologous PRP and were followed up after 3 months. Improvement in pain was evaluated using VAS, the Modified Oswestry Disability Questionnaire (MODQ) index and Straight Leg Raising Test (SLRT). All patients had a gradual improvement in symptoms that persisted for at least three months without any complications.

In 2017, Akeda et al. conducted a clinical study investigating the safety and feasibility of autologous PRP releasate injections for discogenic low back pain (40). PRP releasate is a form of bioactive soluble factors isolated from activated PRP that can stimulate tissue repair. The authors implicated that the platelets were isolated by the buffy coat (BC) method and therefore contained lower concentrations of pro-inflammatory cytokines; hence, the sample was considered as pure PRP. This prospective, preliminary clinical study was carried out in 14 patients with lumbar discogenic low back pain for a period of 10 months. Seventy-one percent of patients showed a 50% reduction in pain as measured by VAS scores; however, low back pain returned in two patients. In contrast to the VAS scores, physical disability scores [Roland-Morris Disability Questionnaire (RDQ)] were significantly reduced in 79% of patients. Apart from temporary leg numbness in two patients, no other notable adverse events were reported. In summary, this study proved the safety, feasibility and efficacy of PRP in the treatment of lumbar discogenic back pain.

A single case report by Lutz [2017] reported on the effectiveness of intradiscal PRP injection for improving low back pain and function (41). The patient was diagnosed with a degenerated disc and had received an ineffective caudal epidural steroid injection and physical therapy. The patient was given a single PRP injection and showed considerable improvement in pain and motion after 6 weeks. At a 1-year follow-up, there was remarkable improvement in low back pain and the patient was able to return to athletic activities.

The clinical studies discussed so far in this review demonstrate the efficacy of autologous PRP when applied alone in the treatment of chronic back pain. Therefore, a report which shows the effect of PRP injection together with another agent [stromal vascular fraction (SVF)] is particularly interesting. Comella et al. investigated the safety and efficacy of PRP in combination with SVF delivered into the disc nucleus of patients with degenerative disc disease (42). SVF is a mixture of adipose-derived stem cells (ADSCs) and growth factors. The study proved to be safe and successful with significant improvements in flexion, VAS, and pain scores according to the Present Pain Intensity (PPI) scale, SF-12 and Dallas Pain Questionnaires (DPQ). The majority of patients reported remarkable reductions in pain compared to baseline over a period of 6 months post-injection. The only side effects reported were soreness in the abdomen from liposuction (for SVF) and soreness in the back from the PRP injection, both of which resolved within 1 week.

A search of unpublished and ongoing clinical work identified three clinical trials evaluating PRP injections for the treatment of low back pain. The details of these studies are presented in .

Ongoing clinical trials to study the effect of platelet-rich-plasma for the treatment of discogenic low back pain (unpublished data)

This review aimed to summarize results from both published and unpublished clinical trials of PRP therapy used in the treatment of discogenic low back pain. The majority of the published clinical studies have applied PRP injections for knee osteoarthritis and epicondylitis, with few reporting its effectiveness for discogenic low back pain. Interestingly, the clinical studies presented here clearly demonstrate the growing interest in PRP injections for treating back pain, with the number of published clinical studies increasing in the past few years. However, it should be noted that there is a lack of RCTs among the reviewed studies ().

The clinical studies that used PRP injections as a therapy for discogenic low back pain reported good results overall. A major and notable advantage of the therapy is the safety of the autologous PRP itself, which does not cause any major complications. Other than a few temporary side effects (soreness at the injection site, numbness in legs), none of the studies reported any serious adverse events or complications resulting from the injections. Because autologous PRP is obtained from the patients own blood, PRP therapy carries low risks of disease infection and allergic reaction (43). In addition, it has been reported that PRP has antimicrobial properties (44,45), which in turn could reduce postsurgical infection risk.

Research on PRP therapy has demonstrated remarkable improvements in pain intensity according to a variety of pain scores. The clinically-beneficial effects have enabled patients to return to normal physical activity (28,41). Notably, the number of injections (single, multiple or at multiple levels), volume of PRP injected (15 mL), initial whole blood volume (920 mL) and follow-up periods (8 weeks18 months) varied across the studies. The PRP isolation procedures used in the studies described in this review remained fairly similar. They involved centrifugation of the patients whole blood and use of a commercial kit or in-house technique.

Even though the clinical application of PRP injection for degenerated discs is gaining popularity, an important aspect which needs to be considered is the age of the target population. The impact of age on the effectiveness of growth factor injections has been previously discussed (14). Likewise, a low number of functional cells in the intervertebral discs of older patients may hinder the efficacy of PRP injections. The PRP therapy will be more efficient if applied before disc degeneration reaches an advanced stage. Another possible approach will be the use of PRP in combination with cellular therapy, such as the use of nucleus pulposus cells.

The cost-effectiveness of PRP therapy remains controversial. In 2013, Hsu et al. reported that it is more expensive than steroid injections when used in the short-term, but potentially less expensive when used for long-term treatment (20). On the other hand, PRP therapy is widely described as cost-effective as it is autologous in nature, simple to prepare and readily available (33,46,47).

Future directions in PRP therapy include conducting more randomized, controlled and unbiased clinical trials to provide higher quality evidence (48). To the best of our knowledge, only a single randomized controlled clinical trial has been conducted on the effectiveness of PRP injections on discogenic low back pain (38). Further research is necessary to investigate the long-term effects of PRP injections, including possible adverse effects, over longer follow-up periods. A possible future clinical direction would be to compare single and multiple injection regimes within the same study. Other aspects such as the method of preparation of PRP including starting whole blood volume, platelet concentration, PRP composition and amount of PRP injected can be further investigated. Additional research on the above aspects will be advantageous to clinicians in providing better guidance and indications for determining individual patient-based treatment plans and, thus, better clinical outcomes.

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Platelet-rich plasma injections: an emerging therapy for ...

Platelet-Rich Plasma Injections Show No Benefit in Knee OA

A large randomized, placebo-controlled trial of platelet-rich plasma injections for knee osteoarthritis has found almost no symptomatic or structural benefit from the treatment, giving some clarity to an evidence base that has seen both positive and negative trials for the treatment modality.

Dr Kim Bennell

Given the need for better disease-modifying treatments for osteoarthritis, there has been a lot of interest in biological therapies such as platelet-rich plasma and stem cells, the lead author of the study, Kim Bennell, PhD, told Medscape Medical News. "People have started to use it to treat osteoarthritis, but the evidence to support it was limited in terms of its quality, and there's been very little work looking at effects on structure," said Bennell, a research physiotherapist and chair of physiotherapy at the the University of Melbourne, Melbourne, Australia.

Platelet-rich plasma contains a range of growth factors and cytokines that are thought to be beneficial in building cartilage and reducing inflammation. There have been several clinical trials of the treatment in knee osteoarthritis, but the current study's authors said these were limited by factors such as a lack of blinding and were at high risk of bias. "That was the impetus to do a large, high-quality study and to look at joint structure," Bennell said.

For the study, which waspublished November 23 in JAMA, the researchers enrolled 288 adults older than 50 with knee osteoarthritis who had experienced knee pain on most days of the past month and had radiographic evidence of mild to moderate osteoarthritis of the tibiofemoral joint.

After having stopped all nonsteroidal anti-inflammatory and pain-relief drugs 2 weeks prior except acetaminophen participants were randomly assigned to receive three weekly intra-articular knee injections of either a commercially available leukocyte-poor platelet-rich plasma or saline placebo. They were then followed for 12 months.

Among the 288 participants in the study, researchers saw no statistically significant difference in the change in pain scores between the treatment and placebo groups at 12 months, although there was a nonsignificantly greater reduction in pain scores among those given platelet-rich plasma. The study also found no statistically significant difference between the two groups in the change in medial tibial cartilage volume.

The researchers also looked at a large number of secondary outcomes, including the effects of treatment on pain and function at 2 months, change in Knee Injury and Osteoarthritis Outcome (KOOS) scores, and change in quality-of-life scores. There were no indications of any benefits from the treatment at the 2-month follow-up, and at 12 months, the study showed no significant improvements in knee pain while walking or in pain scores, KOOS scores, or quality-of-life measures.

However, significantly more participants in the treatment group than in the placebo group reported overall improvement at the 2-month point 48.2% of those in the treatment arm compared with 36.2% of the placebo group (risk ratio, 1.37; 95% CI, 1.05 1.80; P = .02). At 12 months, 42.8% of those who received platelet-rich plasma reported improved function, compared with 32.1% of those in the placebo group (risk ratio, 1.36; 95% CI, 1.00 1.86, P = .05).

The study also found that significantly more people in the platelet-rich plasma group had three or more areas of cartilage thinning at 12 months (17.1% vs 6.8%; risk ratio, 2.71; 95% CI, 1.16 6.34; P = .02).

Even when researchers looked for treatment effects in subgroups for example, based on disease severity, body mass index, or knee alignment they found no significant differences from placebo.

Bennell said the results were disappointing but not surprising. "Anecdotally, people do report that they get better, but we know that there is a very large placebo effect with treatment of pain," she said.

In an accompanying editorialbyJeffrey N. Katz, MD, director of the Orthopaedic and Arthritis Center for Outcomes Research at Brigham and Women's Hospital, professor of medicine and orthopedic surgery at Harvard Medical School, and professor of epidemiology and environmental health at the Harvard T.H. Chan School of Public Health, Boston, Massachusetts, draws parallels between this study and two earlier studies of platelet-rich plasma for ankle osteoarthritis and Achilles tendinopathy, both published in JAMA in 2021. None of the three studies showed any significant improvements over and above placebo.

"These findings emphasize the importance of comparing interventions with placebos in trials of injection therapies," Katz writes. However, he notes that these studies do suggest possible benefits in secondary outcomes, such as self-reported pain and function, and that earlier studies of the treatment had had more positive outcomes.

Katz said it was premature to dismiss platelet-rich plasma as a treatment for knee osteoarthritis, but "until a new generation of trials using standardized approaches to PRP [platelet-rich plasma] therapy provides evidence of efficacy, it would be prudent to pause the use of PRP for OA and Achilles tendinitis."

When asked for comment, sports medicine physician Maarten Moen, MD, from the Bergman Clinics Naarden, the Netherlands, said the study was the largest yet of the use of platelet-rich plasma for knee osteoarthritis and that it was a well-designed, double-blind, placebo-controlled trial.

Dr Maarten Moen

However, he also pointed out that at least six earlier randomized, placebo-controlled studies of this treatment approach have been conducted, and of those six, all but two found positive benefits for patients. "It's a very well-performed study, but for me, it would be a bridge too far to say, 'Now we have this study, let's stop doing it,' " Moen said.

Moen said he would like to see what effect this study had on meta-analyses and systematic reviews of the treatment, as that would give the clearest indication of the overall picture of its effectiveness.

Moen's own experience of treating patients with platelet-rich plasma also suggested that among those who do benefit from the treatment, that benefit would most likely show between 2 and 12 months afterward. He said it would have been useful to see outcomes at 3- and 6-month intervals.

"What I tell people is that on average, around 9 months' effect is to be expected," he said.

Bennell said the research group chose the 12-month follow-up because they wanted to see if there were long-term improvements in joint structure which they hoped for, given the cost of treatment.

The study was funded by the Australian National Health and Medical Research Council, and Regen Lab SA provided platelet-rich plasma kits free of charge. Two authors reported using platelet-rich plasma injections in clinical practice, one reported scientific advisory board fees from Biobone, Novartis, Tissuegene, Pfizer, and Lilly; two reported fees for contributing to UpToDate clinical guidelines, and two reported grants from the National Health and Medical Research Council outside the submitted work. No other conflicts of interest were declared.

JAMA. Published online November 23, 2021. Full text

Bianca Nogrady is a freelance journalist based in Sydney, Australia.

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Platelet-Rich Plasma Injections Show No Benefit in Knee OA

Vampire Facial 2021: My Before and After Pics of PRP Microneedling – Cosmopolitan

Listen, I'm not one to be ~easily influenced~ into trying something just because a celebrity or influencer posts about it. ...Well, okay, except for that one time I tried the viral Hanacure face mask. Or, fine, that other time I ordered Curology (but it really works! Sue me!). Or, ugh, that time I triedand surprisingly lovedsoap brows. But! I can say that I did hold out on trying one incredibly popular trend for years: PRP microneedlingaka the vampire facial. Yup, despite the fact that Kim Kardashian posted a viral selfie of her own vampire facial in 2013, I saw that bloodied towel next to her and decided I'd sit that trend out.

But it's been eight years, and the popularity of vampire facials has yet to die downand for good reason: They're said to help boost collagen production (for tighter, smoother, newer-looking skin) and improve everything from hyperpigmentation to acne scars, so I decided it might be one worth finally trying it for myself and paid a visit to board-certified dermatologist Jordan Carqueville, MD. Never say never, kids. Below, a breakdown of the bloody beauty treatment and a review of my experience trying it for the first time.

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To put it simply, a vampire facial stimulates collagen production in your skin through a combination of microneedling with platelet-rich plasma (PRP). Stay with me. Microneedling, as you probably already know, is a treatment that involves poking your skin with itty-bitty needles to create "micro-injuries." Sounds barbaric, but these little injuries actually trigger your body's wound-healing process to encourage new collagen production (aka the essence of good skin).

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The only difference with a vampire facial is instead of puncturing your skin with bare needles (like with microneedling), it's punctured with your own blood platelets. Yup. Basically, some blood is drawn from your arm, then spun with a centrifuge to separate the plasma and platelets that contain your own growth factorsi.e., platelet-rich plasma (PRP). That PRP is then "microneedled" into the skin and applied on top of the micro-wounds to help stimulate your collagen even more.

It all sounds incredibly ~extra~, but vampire facials (or PRP microneedling, if we're being specific) can help boost collagen production, brighten your overall skin tone, get rid of minor acne scars, fade hyperpigmentation, and tighten your skin.

A vampire facial is microneedlingbut better. Microneedling works great to stimulate collagen on its own, but Dr. Carqueville says that PRP serves as one of the best ways to really boost your collagen by using those concentrated platelets and growth factors in addition to the basic microneedling.

After you heal (which can take up to a week), your skin will look and feel brighter, dewier, more supple, and refreshedbut don't expect those results overnight. Immediately after my treatment, my face was comically red and flushed, and it only softened to a bright-pink (!) for the rest of the day. It also felt tight, tender, and dry, like I'd been swimming in the salty ocean aaaand also got a sunburn. By the next morning, I felt totally normal again, and the redness had significantly improved, but I still had lil red splotches all over my face that took a few days to fade.

According to Dr. Carqueville, how long a vampire facial takes to heal depends on the needle length and the amount of pressure applied. With the stronger treatments, the healing period could last five to seven days, and for a light refresher, two to three days. Since I was in the hands of a physician I trusted, I felt comfortable with a stronger, more aggressive treatment in hopes that I would see some serious results even faster. So needless to say, my face needed the maximum amount of time to heal: one full week.

After your skin heals, you can expect to have a nice, dewy glow for a few weeks, but know that your results will just get better with time. Basically, a vampire facial is an investment toward your future skinit's not an immediate fix. "Collagen stimulation, that tightening and remodeling of your collagen, happens over the course of six months to a year after a procedure like this," Dr. Carqueville explains. I mean, you're quite literally tricking your body into speeding up its natural regenerative process, and that's gonna take some time.

With vampire facials or PRP microneedling, a light refresher once a quarter or even once a year might be enough for someone younger without major acne scarring. But if you're trying to treat deeper acne scars, you might need a series of three sessions spaced four to six weeks apart. "Theres no right or wrong answer, but generally, the cumulative results will be more noticeable with the more treatments you get," Dr. Carqueville says. Your dermatologist will be able to tell you during your consultation how many treatments they think you'll need, so don't stress.

The first few days after your treatment, keep it simple. You've just created wounds that need to heal, so any harsh ingredients like exfoliating acids are a definite no. For the first 48 hours, Dr. Carqueville recommends sticking with just a hyaluronic acid serum and a thin layer of Vaseline on top if your skin feels a little dry. Or, try a bland, basic, fragrance-free moisturizer, and keep your skin makeup free.

If improving pigment (like melasma) is the goal, Dr. Carqueville likes incorporating a dark-spot-correcting cream after a couple of days of initial healing (around 48 to 72 hours after) while it still can penetrate really well. "When you do microneedling, you open up your skin channels to better absorb topical medications," says Dr. Carqueville. "It does help the skin become more amenable to absorbing those active ingredients."

The number-one thing you should not do? Go out in the sun. Dr. Carqueville explains that because vampire facials compromise the top layer of your skin, you dont have as much protection from the sun, so you need to be really cautious. Avoid exposure the best you can during the initial healing period, then use lots of sunscreen and wear all the sun protection gear to keep your skin safe.

The price depends largely upon where you're receiving the treatment, but microneedling alone costs at least $200, on the very low end, and once you throw in the PRP (e.g., the blood draw, centrifuge, etc.), that price will increase to the $1,000-$2,000 range. It's not cheap, but do you really want to bargain shop when you're getting blood drawn and needles stuck in your face? No, no you do not.

On a scale from one to Brazilian bikini wax, Id rate the pain a five. I was numbed up, both with a topical numbing cream and lidocaine injections (honestly, the shots were the worst part), but I still felt the whole treatment and can't imagine going through it if I had full sensation of my face. Basically, numbing is mandatory. All in all, after waiting 45 minutes for the numbing cream to set in, the process was quick, so any pain or discomfort was temporary.

I wish I could look at you in your eyes when saying this because it's *that* important: No, you should not try to DIY a vampire facial at home. Considering all the numbing beforehand and, ya know, the whole drawing and spinning of your blood, this treatment can only be performed by a trained, experienced provider, or ideally, a physician.

Dermarolling, on the other hand, is a treatment much milder than a vampire facial that can be accomplished at home (sans blood) with a needle-covered roller. It doesn't penetrate as deeply (or involve any PRP for that matter), so it isn't nearly as effective as a vampire facial or even in-office microneedling, but as long as you adjust your expectations (and as long as your dermatologist gives you the OK), dermarolling is a much more affordable and accessible treatment.

Ora Microneedle Face Roller System

StackedSkincare Micro-Roller .2mm

BeautyBio GloPRO Microneedling Regeneration Tool

Jenny Patinkin Rose on Rose Derma Roller

Despite the gory nickname and photos, a vampire facial is actually great for your skin. Dr. Carqueville says the side effects of a vampire facial are usually low, as long as it's performed by a physician or experienced provider who's knowledgeable in PRP treatments. Still, as with anything that disrupts the skin barrier, theres always a risk of infection, bruising, redness, swelling, and tenderness, she says. Scarring, hyperpigmentation, and hypo-pigmentation are also risks and can be exacerbated with sun exposure, so here is your second reminder to slather on that sunscreen.

Expensive? Yes. Painful? If you weren't numbed up, probably. Worth it? Absolutely, IMO. Unlike other pricey skin treatments, like chemical peels, you actually get long-term benefits out of a vampire facial by stimulating that collagen in your dermis. It's only been a handful of days since my treatment, so I'm still waiting on my long-term results (and for my face to heal completely, TBH), but I already see improvements and would definitely recommend it to friends.

As long as you've got a week where no one's going to see your face (and you don't have a fear of needles, because there are a lot of those involved), I'd say it's worth all the blood, sweat, and internal tears over my bank account.

I Got a Microcurrent Facial, Now My Skin Is Amaze

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Vampire Facial 2021: My Before and After Pics of PRP Microneedling - Cosmopolitan

Treatment of Keloids Using PSR Combined with Radiation. | CCID – Dove Medical Press

Introduction

Keloids, a type of histologically localized dermal inflammation, are the result of an aberrant healing process featuring abnormal proliferation of fibrous tissue and chronic inflammation after skin injuries reach the reticular dermis.1 Due to the excessive amounts of collagen and glycoprotein accumulating in the dermis, keloids progress and enlarge by growing beyond the boundaries of the original wounds, which distinguishes them from hypertrophic scars. The affected skin usually stiffens and gets pruritic, with various color ranges from pink to dark brown.

The current mainstays of treating hypertrophic scars and keloids remain nonstandard with multiple modalities involved, including surgical excision, intralesional steroids, silicone gel, pressure therapy and laser therapy. Surgical excision alone has been proved to result in high recurrence rate because of post-traumatic collagen synthesis stimulation, while subtotal excision with lateral undermining might possibly improve outcome.2 In recent years, several studies reported low recurrence rate by following surgical excision with other modalities, usually radiation therapy or intralesional steroids injection.3,4 Silicone gel, often used as adjuvant treatment after surgery or laser, has also been reported by some studies to be effective in reducing recurrence rate.5 Laser therapy includes a series of treatment modalities including neodymium-doped yttrium aluminium garnet (Nd:YAG) laser, carbon dioxide laser and diode laser.68 Though laser treatment alone had less effectiveness on keloid than hypertrophic scar with high recurrence rate, a combination of laser and other single-application treatments such as silicone gel, and intralesional steroid injections were proven to be an effective and safe therapeutic approach.8

In recent years, a novel device, plasma skin regeneration system (PSR) is applied to treat mesh skin-grafted scars and traumatic scars.9 Unlike laser therapy which directly applies radio frequency to skin, PSR uses radio frequency to convert nitrogen to plasma, a high-energy state of matter that is emitted at 515 millisecond pulses to deliver 14 J of energy.9 Plasma then conveys energy to the wounded skin and causes a thermal effect that gasifies proliferative fibrous tissue in the dermis. The effect on skin rejuvenation depends on the amount of plasma energy delivered. Thus, it enables operators to adopt various energy levels and different number of treatments to different wound types and locations.

In this study, the authors innovatively removed keloids with PSR. Given that single treatment may result in high recurrence rate, the authors administrated adjuvant radiotherapy. Radiation therapy has been illustrated to be effective in the control of keloid recurrence by inducing keloid fibroblast apoptosis and destroying collagen structure.2,10 The aim of this study is to evaluate the effectiveness and safety of PSR combined with radiation therapy in the treatment of keloids on different body parts.

This study was conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the ethics committee of Peking Union Medical College Hospital. Patient data confidentiality was maintained in accordance with the regulations. Written informed consent was waived in light of the retrospective nature of this study. A total of 71 consecutive patients (aged 1569) with 98 dermal lesions clinically diagnosed as keloids were enrolled in this uncontrolled prospective study, with stipulated selection criteria. The skin types of enrolled patients were type III or IV. The over-extensive growth pattern unconfined to the original wound edges was required as a clinical distinction of keloids from hypertrophic scars.

Patients were excluded from this study if they had previously undergone at least one of the following treatments within the last six months: surgical excision, free-flap grafting, carbon dioxide resurfacing, triamcinolone intralesional injection, silicone gel sheeting, and pressure therapy. Pregnant and lactating patients and those with systemic comorbidities including cardiovascular diseases, diabetes mellitus, and chronic renal failure were also excluded to avoid unnecessary potential risks.

A clinical evaluation process was developed primarily based on the number, thickness, and texture of the lesions (Figure 1). Each patient admitted for the treatment of keloids underwent this evaluation process. PSR was mainly applied for progressive keloids with multiple lesions. Ideal lesions were no thicker than 4 mm. Patients whose keloids were thicker than 10 mm were recommended not to receive this treatment, because thick lesions needed high level of energy and too much energy would cause severe side effects. For lesions 4 to 10mm thick or those much stiffer than usual, we administered intralesional injections of betamethasone (Diprospan) to soften the lesions before PSR.

Figure 1 Clinical evaluation and treatment process for keloids.

Plasma was administrated to qualified keloid lesions right after subdermal injection of 0.5% lidocaine (540mL, depending on the size of lesion), which spared patients from pain when receiving PSR treatment. Doctors resurfaced the lesions using PSR, making them as flat as the surrounding skin. The patients were asked to cover the lesion with topical antibacterial spray to prevent potential topical infection. External beam irradiation was administered with a total dose of 18 Gy in two fractions, one week apart. Specifically, the first radiation therapy was performed within 24 hours after treatment, and the second was performed 1 week later. The minimum follow-up period was 12 months.

Digital photographs were taken to record the morphological characteristics of the keloids before treatment, immediately after treatment and at the end of follow-up. The patient and observer scar assessment scale (POSAS) was used to evaluate the effect of PSR.11 Both patients and observers were asked to fill in the numeric scale before treatment and 12 months posttreatment. To avoid bias, the POSAS observer study was performed independently by an experienced plastic surgeon who was not involved in the treatment.

Means and standard deviations were calculated for each variable. The Students t-test was performed using SPSS 23.0 (IBM, New York, USA) to analyze and summarize all the original data. P values of <0.05 were considered statistically significant.

A total of 71 patients (32 males and 39 females) were enrolled in our study. The demographics are summarized in Table 1. Twenty-nine patients were self-reported to have clear incentive such as acne, trauma, and surgical incision. Moreover, 33 patients reported familial inheritance. The 98 lesions were distributed as follows: 23 lesions (23.5%) on face and neck, 26 (26.5%) on chest, 16 (16.3%) on shoulders, 16 (16.3%) on the back and 17 (17.3%) on limbs. The average lesion size was 5.030.72 cm. The average re-epithelization duration was 33.7810.46 days.

Table 1 Patient Demographics

According to the patients (Table 2), POSAS scoring showed a significant improvement in the 98 keloids, with the mean score decreasing from 35.059.94 before treatment to 21.847.04 (p value <0.05). The mean score of keloids on the face and neck dropped significantly from 36.4310.60 to 20.006.62 (p value <0.05), with an improvement over 40%. The mean score of keloids on chest and back also decreased from 41.0810.29 and 29.564.16 to 24.157.82 (p value <0.05) and 18.195.31 (p value <0.05), respectively. However, improvement of keloids on shoulders and limbs was limited though still statistically significant. Table 3 demonstrates the six items that were evaluated by each patient. Comprehensive improvements were made on all items. Amelioration on pain and itchiness was over 50%.

Table 2 Total Patient-Reported Scores of Keloids on Different Body Parts Before and After Treatment

Table 3 Results of POSAS According to Patients

The results from the independent observer (Table 4) and the patients were consistent. The mean score of all 98 keloids dropped from 37.598.17 to 23.477.53 (p value <0.05). Keloids on face and neck, chest and back responded better to the treatment than those on shoulders and limbs. The observer score of six items is shown in Table 5. All items were significantly improved. Pigmentation (the extent of improvement in color) and relief (the extent of improvement in irregularities) were not improved remarkably as compared to the other four items, which corresponded with the results from the patient score. Figures 2Figures 3Figures 4Figures 5 showed keloids on different locations before and after treatment.

Table 4 Total Observer-Reported Scores of Keloids on Different Body Parts Before and After Treatment

Table 5 Results of POSAS According to Observer

Figure 2 A patient with multiple lesions of keloids on his face prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Figure 3 A patient with multiple lesions of keloids on his chest prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Figure 4 A patient with multiple lesions of keloids on her shoulder prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Figure 5 A patient with multiple lesions of keloids on her arm prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Adverse effects after radiation therapy are summarized in Table 6. Erythema and edema were common complications that occurred to almost all patients, but soon disappeared without special treatment. Local infection was reported by eight patients, and the type of infection was acne folliculitis. It was the main reason for which patients revisited our center in weeks after treatment. Late adverse effects included hyperpigmentation, hypopigmentation and radiation dermatitis. No case of carcinogenesis was reported. Complications of PSR were mild. Hyperpigmentation and hypopigmentation were complaints made by seven and five patients, respectively. During follow-up, 15 keloids (15.3%) were observed or reported to relapse. Recurrent lesions were further treated with dye laser or steroid injection.

Table 6 Summary of Adverse Effects

Keloid has long bothered clinicians and patients as there is no standard therapy that gains universally approval. Single treatment, either surgical excision or laser therapy, has been repeatedly proven to result in high recurrence rate.12 In the light of this, combination of keloid removal and adjuvant therapy has received much attention and increasingly more studies have shown its effectiveness with low recurrence rate.35 Adjuvant therapy includes a series of treatments that are administrated after surgical excision or laser therapy. Radiation therapy, steroid injection and silicone gel have all been reported to be effective adjuvant therapies. Park and Rah treated helical rim keloids with surgical excision plus silicone gel pressure therapy.13 The therapy protocol resulted in improvement on most items in the POSAS with recurrence-free rate of 95%. Garg et al evaluated the effect of CO2 laser ablation followed by steroid injection.14 Their study illustrated that CO2 laser alone was not efficient enough while adding steroid injection as adjuvant therapy could significantly reduce recurrence rate. Hersant et al reported a pilot study using platelet-rich plasma injection as adjuvant therapy to surgical excision.15 Vancouver Scar Scale score was reduced by more than 50% after 2-year follow-up though 29% of keloids relapsed. Considering that the keloids of interest did not respond to conventional therapies, it was a satisfactory result.

Multiple treatments of PSR have been proven to be clinically effective for traumatic scars, mesh skin-grafted scars, and wrinkles at an interval of 3 weeks to 1 month.9,16 In this study, we reported single-dose PSR treatment combined with radiotherapy as an effective management for keloids. The endpoint of PSR therapy was when the lesions were almost as flat as the surrounding normal skin although red in color. More energy was applied for thicker lesions. An intralesional injection of the compound betamethasone was administered before PSR for thick lesions (thickness >4 mm) to avoid excessive plasma irradiation that could cause serious side effects and longer recovery time. However, for keloids less thick than 4 mm, PSR was administered without the steroid injection.17 After PSR, a total of 18 Gy of radiation were administrated in two fractions, 24 hours posttreatment and again 1 week later. We regard adjuvant radiotherapy important in the prevention of recurrence. Numerous studies have shown surgery excision alone was followed by high recurrence rate, and that radiation therapy after keloid removal could significantly reduce recurrence rate to a desirable level.2,3 The mechanism of radiotherapeutic prevention remains unclear. One possible explanation is suggested to be the elimination of abnormally activated fibroblasts and stimulation of normal ones.18 Kal et al recommended biologically effective dose for keloid prevention should be 3040 Gy, which could be achieved by either a single fraction of 1315 Gy or 1720 Gy in 2 fractions.19 Furthermore, radiotherapy was advocated to be administrated immediately after keloid removal or within 2 days.20 We strictly complied with these suggestions in this study.

Plasma combined with radiation therapy results in good clinical outcome, though improvement varies on different body parts. Keloids on face and neck, chest and back were significantly improved after treatment according to both patients and observers. However, improvement of keloids on shoulders and limbs was limited. The frequent movement of these body parts results in high stretch tension that impedes collagen renewal and dermal remodeling. Though excessive proliferative fibrous tissue is removed, the rebuilding process of dermal architecture is relatively slower than that of lesions with less stretch tension.

In this study, complications are categorized by treatment area and duration. Complications after radiation therapy are considered adverse effects that occur within the radiation field beyond the lesion. Complications that limit to the lesion area are PSR-related. Acute adverse effects are defined as complications that disappeared within 4 weeks, while long-term adverse effects usually last longer than 1 month.

In terms of complications after radiation therapy, erythema and edema were reported by almost all patients in the first few days, but usually disappeared in 2 weeks without medication. In our follow-up, no patients resorted to medical treatment for long-lasting erythema or edema. Speranza et al confirmed that erythema was the most frequent acute side effect, but it had no association with patient satisfaction.21 Late complications reported by our patients include skin color change and chronic radiodermatitis. Permanent pigmentation and depigmentation are commonly reported to be a major late complication with incidence rate varying from 30% to 60% according to other studies.21,22 In this study, no case of necrosis or carcinogenesis was reported. Risk of radiation-induced tumor has been repeatedly proven to be very low.22 However, clinicians should always be cautious about the radiation energy in total when applying adjuvant radiotherapy. Sakamoto et al illustrated that relapse rate and adverse-effect were both dose-related.23 They recommended an optimal dose of 20 Gy in five fractions. We agreed that 18 Gy in 2 fractions is a nice balance between adverse effects and recurrence rate.

A few lesions developed hyperpigmentation or hypopigmentation limited to the area that received PSR treatment. These complications were considered PSR-related and had nothing to do with radiation therapy. Lesions with PSR-related complications were all thicker than 4mm before treatment. However, it should be mentioned that not every thick lesion developed these complications. We speculate that this is because intralesional injection of steroid is insufficient for some thick lesions. Thick lesions with insufficient steroid are not completely soften and thus require more energy to be flatten. The high energy level leads to adverse effects that do not develop at lower level of energy. In general, PSR should be considered a safe therapy with mild complications. An in vivo study showed that PSR could consistently achieve thermal injury into the papillary dermis resulting in collagen remodeling without permanent pigmentary or textural irregularities.24 Other studies also confirmed that PSR treatment caused less complications. According to Fosters study, no patient developed permanent hypopigmentation, a complication that is generally observed in 820% of CO2 resurfacing patients, although a very small proportion (4%) of patients reported transient hyperpigmentation, which should be treated with hydroquinone creams or combination creams containing a mild topical corticosteroid, retinoid, and hydroquinone.25 Fitzpatrick et al reported that the thermal damage by PSR for any energy level was at most equivalent to medium fluence of the carbon dioxide laser and that the damage was confined within 15 m depth, in contrast to 33.4 m thermal damage created by high fluence of the carbon dioxide laser.26

In fact, not many risk factors other than ancestry, early age and skin injuries are known about keloid. But even less is known about factors that could possibly affect long-term curative effect. For example, sexuality, age, familial inheritance, and lesion size are all possible to influence clinical improvement. This study indicates keloids on different body parts may respond differently to the combination therapy. In the future, other factors that affect clinical outcome should be further studied with keloid location as a control factor.

This study has some limitations. Firstly, this is an observational study that evaluates the effectiveness and safety of PSR with adjuvant radiation therapy, while it does not compare PSR with other common treatment modalities. Randomized controlled studies are necessary for further evaluation of PSR. Secondly, the observation period of this study is relatively short to evaluate long-term curative effect, as previous studies reported that the control rate of keloid decreased 5 or 10 years or more after treatment.27,28 Thirdly, this study used a standardized scale for the evaluation of therapeutic effects. It has been mentioned that scale evaluation is subjected to a number of human factors and that objective assessment tools should be advocated.29 Application of objective assessment tools such as laser speckle contrast imaging and three-dimensional imaging could yield quantitative and more robust results.30,31

Plasma Skin Regeneration combined with adjuvant radiation therapy should be regarded as a safe, low-risk, effective treatment for keloids. Steroid could be administrated for thick lesions before PSR to avoid excessive thermal effect that increases the rate of side effects.

The authors declare no conflicts of interest for this work.

1. Ogawa R. Keloid and hypertrophic scars are the result of chronic inflammation in the reticular dermis. Int J Mol Sci. 2017;18(3):606.

2. Al-Attar A, Mess S, Thomassen JM, Kauffman CL, Davison SP. Keloid pathogenesis and treatment. Plast Reconstr Surg. 2006;117(1):286300. doi:10.1097/01.prs.0000195073.73580.46

3. Jones ME, Ganzer CA, Bennett D, Finizio A. Surgical excision of keloids followed by in-office superficial radiation therapy: prospective study examining clinical outcomes. Plast Reconstr Surg Glob Open. 2019;7(5):e2212. doi:10.1097/GOX.0000000000002212

4. Chua SC, Gidaszewski B, Khajehei M. Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol. Trials. 2019;20(1):363. doi:10.1186/s13063-019-3465-6

5. Stromps JP, Dunda S, Eppstein RJ, Babic D, Har-Shai Y, Pallua N. Intralesional cryosurgery combined with topical silicone gel sheeting for the treatment of refractory keloids. Dermatol Surg. 2014;40(9):9961003. doi:10.1097/01.DSS.0000452627.91586.cc

6. Koike S, Akaishi S, Nagashima Y, Dohi T, Hyakusoku H, Ogawa R. Nd:YAG laser treatment for keloids and hypertrophic scars: an analysis of 102 cases. Plast Reconstr Surg Glob Open. 2014;2(12):e272. doi:10.1097/GOX.0000000000000231

7. Henderson DL, Cromwell TA, Mes LG. Argon and carbon dioxide laser treatment of hypertrophic and keloid scars. Lasers Surg Med. 1984;3(4):271277. doi:10.1002/lsm.1900030402

8. Li K, Nicoli F, Xi WJ, et al. The 1470 nm diode laser with an intralesional fiber device: a proposed solution for the treatment of inflamed and infected keloids. Burns Trauma. 2019;7:5. doi:10.1186/s41038-019-0143-6

9. Kono T, Groff WF, Sakurai H, Yamaki T, Soejima K, Nozaki M. Treatment of traumatic scars using plasma skin regeneration (PSR) system. Lasers Surg Med. 2009;41(2):128130. doi:10.1002/lsm.20723

10. Berman B, Maderal A, Raphael B. Keloids and hypertrophic scars: pathophysiology, classification, and treatment. Dermatol Surg. 2017;43(Suppl 1):S3S18. doi:10.1097/DSS.0000000000000819

11. Draaijers LJ, Tempelman FRH, Botman YAM, et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004;113(7):19601965. doi:10.1097/01.PRS.0000122207.28773.56

12. Arno AI, Gauglitz GG, Barret JP, Jeschke MG. Up-to-date approach to manage keloids and hypertrophic scars: a useful guide. Burns. 2014;40(7):12551266. doi:10.1016/j.burns.2014.02.011

13. Park TH, Rah DK. Successful eradication of helical rim keloids with surgical excision followed by pressure therapy using a combination of magnets and silicone gel sheeting. Int Wound J. 2017;14(2):302306. doi:10.1111/iwj.12547

14. Garg GA, Sao PP, Khopkar US. Effect of carbon dioxide laser ablation followed by intralesional steroids on keloids. J Cutan Aesthet Surg. 2011;4(1):26. doi:10.4103/0974-2077.79176

15. Hersant B, SidAhmed-Mezi M, Picard F, et al. Efficacy of autologous platelet concentrates as adjuvant therapy to surgical excision in the treatment of keloid scars refractory to conventional treatments: a Pilot Prospective Study. Ann Plast Surg. 2018;81(2):170175. doi:10.1097/SAP.0000000000001448

16. Theppornpitak N, Udompataikul M, Chalermchai T, Ophaswongse S, Limtanyakul P. Nitrogen plasma skin regeneration for the treatment of mild-to-moderate periorbital wrinkles: a prospective, randomized, controlled evaluator-blinded trial. J Cosmet Dermatol. 2019;18(1):163168. doi:10.1111/jocd.12767

17. Park KY, Lee Y, Hong JY, Chung WS, Kim MN, Kim BJ. Vibration anesthesia for pain reduction during intralesional steroid injection for keloid treatment. Dermatol Surg. 2017;43(5):724727. doi:10.1097/DSS.0000000000001040

18. Stadelmann WK, Digenis AG, Tobin GR. Physiology and healing dynamics of chronic cutaneous wounds. Am J Surg. 1998;176:28S38S. doi:10.1016/S0002-9610(98)00183-4

19. Kal HB, Veen RE, Jurgenliemk-Schulz IM. Dose-effect relationships for recurrence of keloid and pterygium after surgery and radiotherapy. Int J Radiat Oncol Biol Phys. 2009;74(1):245251. doi:10.1016/j.ijrobp.2008.12.066

20. Bischof M, Krempien R, Debus J, Treiber M. Postoperative electron beam radiotherapy for keloids: objective findings and patient satisfaction in self-assessment. Int J Dermatol. 2007;46:971975. doi:10.1111/j.1365-4632.2007.03326.x

21. Speranza G, Sultanem K, Muanza T. Descriptive study of patients receiving excision and radiotherapy for keloids. Int J Radiat Oncol Biol Phys. 2008;71(5):14651469. doi:10.1016/j.ijrobp.2007.12.015

22. Ogawa R, Yoshitatsu S, Yoshida K, Miyashita T. Is radiation therapy for keloids acceptable? The risk of radiation-induced carcinogenesis. Plast Reconstr Surg. 2009;124(4):11961201. doi:10.1097/PRS.0b013e3181b5a3ae

23. Sakamoto T, Oya N, Shibuya K, Nagata Y, Hiraoka M. Dose-response relationship and dose optimization in radiotherapy of postoperative keloids. Radiother Oncol. 2009;91(2):271276. doi:10.1016/j.radonc.2008.12.018

24. Tremblay JF, Moy RL. Treatment of post-auricular skin using a novel plasma resurfacing system: an in vivo clinical and histologic study. Lasers Surg Med. 2004;34:25.

25. Foster KW, Moy RL, Fincher EF. Advances in plasma skin regeneration. J Cosmet Dermatol. 2008;7:169179. doi:10.1111/j.1473-2165.2008.00385.x

26. Fitzpatrick R, Bernstein E, Iyer S, Brown D, Andrews P, Penny K. A histopathologic evaluation of the Plasma Skin Regeneration System (PSR) versus a standard carbon dioxide resurfacing laser in an animal model. Lasers Surg Med. 2008;40(2):9399. doi:10.1002/lsm.20547

27. Shen J, Lian X, Sun Y, et al. Hypofractionated electron-beam radiation therapy for keloids: retrospective study of 568 cases with 834 lesions. J Radiat Res. 2015;56(5):811817. doi:10.1093/jrr/rrv031

28. Maemoto H, Iraha S, Arashiro K, Ishigami K, Ganaha F, Murayama S. Risk factors of recurrence after postoperative electron beam radiation therapy for keloid: comparison of long-term local control rate. Rep Pract Oncol Radiother. 2020;25(4):606611. doi:10.1016/j.rpor.2020.05.001

29. Chong Y, Long X, Ho YS. Scientific landscape and trend analysis of keloid research: a 30-year bibliometric review. Ann Transl Med. 2021;9(11):945. doi:10.21037/atm-21-508

30. Xu C, Ting W, Teng Y, Long X, Wang X. Laser speckle contrast imaging for the objective assessment of blood perfusion in keloids treated with dual-wavelength laser therapy. Dermatol Surg. 2021;47(4):e117e121. doi:10.1097/DSS.0000000000002836

31. Ruccia F, Zoccali G, Cooper L, Rosten C, Nduka C. A three-dimensional scar assessment tool for keloid scars: volume, erythema and melanin quantified. Skin Res Technol. 2021; Epub. doi:10.1111/srt.13050

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Treatment of Keloids Using PSR Combined with Radiation. | CCID - Dove Medical Press