Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing Positive Effect of Platelet-Rich Plasma Versus Corticosteroid Injection in Lateral Epicondylitis: A Double-Blind Randomized Controlled Trial With 2-year Follow-up [In Process Citation] Am J Sports Med (United States), Jun 2011, 39(6) p1200-8.
DR. REEVES’ NOTES:
This randomized controlled trial, of moderate size, demonstrated that a single injection of steroid is comparable in benefit to a single injection of platelet rich plasma (PRP) but that results were positive for only months for steroids. Benefit from PRP was able to be demonstrated at 2 year follow-up. Thus PRP has more potential benefit for long term benefit than steroid injection for tennis elbow.
Below is a copy of the abstract:
BACKGROUND:
Platelet-rich plasma (PRP) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages.
PURPOSE:
This trial was undertaken to determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up.
STUDY DESIGN:
Randomized controlled trial; Level of evidence, 1.
METHODS:
The trial was conducted in 2 Dutch teaching hospitals. One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group (n = 51) or the corticosteroid group (n = 49). Randomization and allocation to the trial group were carried out by a central computer system. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder and Hand (DASH) outcome scores.
RESULTS:
The PRP group was more often successfully treated than the corticosteroid group (P < .0001). Success was defined as a reduction of 25% on VAS or DASH scores without a reintervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2-year follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned to baseline levels, while those of the PRP group significantly improved (as-treated principle). There were no complications related to the use of PRP.
CONCLUSION:
Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of 2 years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.
Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE Comparison of Autologous Blood, Corticosteroid, and Saline Injection in the Treatment of Lateral Epicondylitis: A Prospective, Randomized, Controlled Multicenter Study. J Hand Surg Posted July 1. June 2011 E pub
DR. REEVES’ NOTES:
Wolf et al in 2011 published a multicenter trial comparing saline, steroid and blood for tennis elbow. This study shows “no difference between steroid, blood and ‘placebo.’” This study contributes to the literature primarily by showing two fatal design flaws that should be avoided when doing research on prolotherapy.
One is to choose a study size so small that a difference between groups cannot be seen. Unfortunately, with funding limitations for prolotherapy research cost factors make large size study designs very difficult to achieve.
The second is choosing an injection control and thinking it will be a placebo.
Below is a copy of the abstract:
PURPOSE:
We compared saline, corticosteroid, and autologous blood injections for lateral epicondylitis in a prospective, blinded, randomized, controlled trial. The null hypothesis was that patient-rated outcomes after autologous blood injection would not be superior to corticosteroid and saline injections.
METHODS:
Patients with clinically diagnosed lateral epicondylitis of less than 6 months’ duration were randomized into 1 of 3 groups to receive a 3-ml injection of saline and lidocaine, corticosteroid and lidocaine, or autologous blood and lidocaine. Of 34 subjects who enrolled, 28 completed follow-up. A total of 10 were randomized to the saline group, 9 to the autologous blood group, and 9 to the steroid group.
Every participant had 3 ml blood drawn, and the injection syringe was foil-covered to prevent the subject from knowing the contents. The primary outcome measure was the Disabilities of the Arm, Shoulder, and Hand (DASH) score. Patients completed a pain visual analog scale, DASH, and the Patient-Rated Forearm Evaluation before injection and at 2 weeks, 2 months, and 6 months after injection. We performed statistical analysis using repeated measures of analyses of variance.
RESULTS:
There were no significant differences in DASH scores among the 3 groups at 2- and 6-month follow-up points, with the mean scores for saline at 20 and 10, respectively, compared with 28 and 20 for autologous blood and 28 and 13 for steroid injections. Secondary measures showed similar findings, with outcomes scores showing improvement in all 3 groups.
CONCLUSIONS:
In this prospective, randomized, controlled trial, autologous blood, corticosteroid, and saline injection provide no advantage over placebo saline injections in the treatment of lateral epicondylitis. Patients within each injection group demonstrated improved outcome scores over a 6-month period.
TYPE OF STUDY/LEVEL OF EVIDENCE:
Therapeutic Tennis Elbow (Lateral epicondylosis) Whole Blood versus PRP in Those Resistant to Physical Therapy. In a large, adequately powered study (IE 70-80 in each group) the effect of PRP and whole blood were compared in subjects with failure to respond to conservative therapy. Two injections were given and no significant difference was noted in outcome.
Creaney L; Wallace A; Curtis M; Connell D. Growth factor-based therapies provide additional benefit beyond physical therapy in resistant elbow tendinopathy: a prospective, single-blind, randomised trial of autologous blood injections versus platelet-rich plasma injections [In Process Citation] Br J Sports Med (England), Sep 2011, 45(12) p966-71
A copy of the abstract is available below:
ABSTRACT:
Background Growth factor technologies are increasingly used to enhance healing in musculoskeletal injuries, particularly in sports medicine. Two such products; platelet-rich plasma (PRP) and autologous blood, have a growing body of supporting evidence. No previous trial has directly compared the efficacy of these two methods.
HYPOTHESIS:
Growth factor administration improves tissue regeneration in patients who have failed to respond to conservative therapy. Study design A prospective, double-blind, randomised trial.
METHODS:
Elbow tendinopathy patients who had failed conservative physical therapy were divided into two patient groups: PRP injection (N=80) and autologous blood injection (ABI) (N=70). Each patient received two injections at 0 and 1 month. Patient-related tennis elbow evaluation (PRTEE) was recorded by a blinded investigator at 0, 1, 3 and 6 months. The main outcome measure was PRTEE, a validated composite outcome for pain, activities of daily living and physical function, utilising a 0-100 scale.
RESULTS:
At 6 months the authors observed a 66% success rate in the PRP group versus 72% in the ABI group, p=NS. There was a higher rate of conversion to surgery in the ABI group (20%) versus the PRP group (10%).
CONCLUSION:
In patients who are resistant to first-line physical therapy such as eccentric loading, ABI or PRP injections are useful second-line therapies to improve clinical outcomes. In this study, up to seven out of 10 additional patients in this difficult to treat cohort benefit from a surgery-sparing intervention.
Peerbooms JC, Sluimer J, Burijn DJ, Gosens T. Positive Effect of an Autologous Platelet Concentrate in Lateral Epicondylitis in a Double-Blind Randomized Controlled Trial: Platelet-Rich Plasma Versus Corticosteroid Injection With a 1-Year Follow-up Am J Sports Med 2010 38:255-262.
DR. REEVES’ NOTES:
This was a good-sized trial with 100 patients. PRP group better at 1 year outcome with a single injection with peppering technique than with corticosteroid injection in this blinded study. Note that there was no control group without injection and steroid may be a somewhat harmful treatment ultimately. Success was defined as a 25% reduction in pain or DASH score (explained below) at 1 year and was 73% with PRP versus 49% in the steroid group. Steroid injected patients felt better quicker but did not do as well on longer term followup.
The complete study on Tennis Elbow is available in PDF format here.
A copy of the abstract is below:
BACKGROUND:
Platelet-rich plasma (PRP) has shown to be a general stimulation for repair. Purpose: To determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis.
STUDY DESIGN:
Randomized controlled trial
Level of evidence: Patients: The trial was conducted in 2 teaching hospitals in the Netherlands. One hundred patients with chronic lateral epicondylitis were randomly assigned in the PRP group (n 5 51) or the corticosteroid group (n 5 49). A central computer system carried out randomization and allocation to the trial group. Patients were randomized to receive either a corticosteroid injection or an autologous platelet concentrate injection through a peppering technique. The primary analysis included visual analog scores and DASH Outcome Measure scores (DASH: Disabilities of the Arm, Shoulder, and Hand).
RESULTS:
Successful treatment was defined as more than a 25% reduction in visual analog score or DASH score without a reintervention after 1 year. The results showed that, according to the visual analog scores, 24 of the 49 patients (49%) in the corticosteroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was significantly different (P\.001). Furthermore, according to the DASH scores, 25 of the 49 patients (51%) in the corticosteroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was also significantly different (P 5 .005). The corticosteroid group was better initially and then declined, whereas the PRP group progressively improved.
CONCLUSION:
Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and significantly increases function, exceeding the effect of corticosteroid injection. Future decisions for application of the PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.
Ozturan KE, Yucel I, Cakici H, Guven M, Sungur I. Autologous Blood and Corticosteroid Injection and Extracoporeal Shock Wave Therapy in the Treatment of Lateral Epicondylitis. ORTHOPEDICS 2010; 33:84
DR. REEVES’ NOTES:
This was a randomized control trial. 5 insertions of the needle were made so there was needle trauma in the steroid and the autologous blood group. If the blood group were not 50% better at 1 month they were given a 2nd treatment. The long term results favored the non steroid groups in functional testing measures. Given the spontaneous remission in tennis elbow in many in 6-24 months, this outcome, despite a non injection group control suggests that autologous blood which is low cost, may be the most cost effective treatment approach to treatment of lateral epicondylosis. More peppering may be helpful but has a downside of more trauma potential to small radial nerve branches.
The complete study on Blood vs Steroid vs Shock Wave Therapy is available in PDF format here.
A copy of the abstract on Blood vs Steroid vs Shock Wave Therapy is available here, with a copy of the content below.
Lateral epicondylitis is a common disorder characterized by pain and tenderness over the lateral epicondyle. It occurs most frequently as a result of minor, unrecognized trauma during sports activities and occupation-related physical activities. The goal of this study was to evaluate the short-, medium-, and long-term effects of corticosteroid injection, autologous blood injection, and extracorporeal shock wave therapy in the treatment of lateral epicondylitis. Sixty patients (32 women, 28 men) with lateral epicondylitis were randomly divided into 3 groups: group 1 received a corticosteroid injection; group 2, an autologous blood injection, and group 3, extracorporeal shock wave therapy. Thomsen provocative testing, upper extremity functional scores, and maximal grip strength were used for evaluation. Outcomes were assessed at 4, 12, 26, and 52 weeks. Corticosteroid injection gave significantly better results for all outcome measures at 4 weeks; success rates in the 3 groups were 90%, 16.6%, and 42.1%, respectively.
Autologous blood injection and extracorporeal shock wave therapy gave significantly better Thomsen provocative test results and upper extremity functional scores at 52 weeks; the success rate of corticosteroid injection was 50%, which was significantly lower than the success rates for autologous blood injection (83.3%) and extracorporeal shock wave therapy (89.9%). Corticosteroid injection provided a high success rate in the short term. However, autologous blood injection and extracorporeal shock wave therapy gave better long-term results,especially considering the high recurrence rate with corticosteroid injection. We suggest that the treatment of choice for lateral epicondylitis be autologous blood injection.
Scarpone M, Rabago DP, Zgierska A, Arbogast G, Snell E. The efficacy of prolotherapy for lateral epicondylosis: a pilot study. Clin J Sport Med (United States), May 2008, 18(3) p248-54
DR. REEVES’ NOTES:
Randomized and blinded trial Injection of combination of sodium morrhuate (.72%) and dextrose (10.7%) on 3 occasions in patients with tennis elbow (lateral epicondylosis) resulted in marked improvement in pain, wrist extension and grip strenth in comparison to injection of saline.
Dr Scarpone et al reported this year in a randomized and controlled study that 12 adults with lateral epicondylosis injected at 0, 1 and 3 months with 0.72% sodium morrhuate, 10.7% dextrose, .29% lidocaine and .04% sensorcaine improved far more in pain levels (91% versus 33%; P < .001) and extension strength (P < .01) and grip strength (P < .05) than 12 subjects given saline injection with the same number of needle punctures and volume. Note this is despite the fact that saline injection is not a placebo, suggesting that saline injection is indeed not equivalent to injection of a combination of sodium morrhuate and dextrose. Although a small study, these results and this design are excellent. From the Department of Family Medicine, University of Wisconsin-Madison, Madison, Wisconsin.
A copy of the abstract on Tennis Elbow is available here, with a copy of the content below.
OBJECTIVES:
To assess whether prolotherapy, an injection-based therapy, improves elbow pain, grip strength, and extension strength in patients with lateral epicondylosis.
SETTING:
Outpatient Sport Medicine clinic.
STUDY DESIGN:
Double-blind randomized controlled trial.
PARTICIPANTS:
Twenty-four adults with at least 6 months of refractory lateral epicondylosis.
INTERVENTION:
Prolotherapy participants received injections of a solution made from 1 part 5% sodium morrhuate, 1.5 parts 50% dextrose, 0.5 parts 4% lidocaine, 0.5 parts 0.5% sensorcaine and 3.5 parts normal saline. Controls received injections of 0.9% saline. Three 0.5-ml injections were made at the supracondylar ridge, lateral epicondyle, and annular ligament at baseline and at 4 and 8 weeks.
OUTCOME MEASURES:
The primary outcome was resting elbow pain (0 to 10 Likert scale). Secondary outcomes were extension and grip strength. Each was performed at baseline and at 8 and 16 weeks. One-year follow-up included pain assessment and effect of pain on activities of daily living. RESULTS: The groups were similar at baseline. Compared to Controls, Prolotherapy subjects reported improved pain scores (4.5 +/- 1.7, 3.6 +/- 1.2, and 3.5 +/- 1.5 versus 5.1 +/- 0.8, 3.3 +/- 0.9, and 0.5 +/- 0.4 at baseline and at 8 and 16 weeks, respectively). At 16 weeks, these differences were significant compared to baseline scores within and among groups (P < 0.001). Prolotherapy subjects also reported improved extension strength compared to Controls (P < 0.01) and improved grip strength compared to baseline (P < 0.05). Clinical improvement in Prolotherapy group subjects was maintained at 52 weeks. There were no adverse events.
CONCLUSIONS:
Prolotherapy with dextrose and sodium morrhuate was well tolerated, effectively decreased elbow pain, and improved strength testing in subjects with refractory lateral epicondylosis compared to Control group injections.
Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. American Journal of Sports Medicine Dec 2006 Volume 34: 1774-1778
Dr. Reeves’ Notes: 141 consecutive patients with elbow epicondylar pain. Patients that failed a standardized physical therapy protocol and a variety of other nonoperative treatments (20) were assigned to treatment with either PRP (15) or bupivicaine (5) injection. The groups were non blinded. (non blinded control). At 8 weeks improvements in pain were 60% in the PRP and 16% in the bupivicaine group. Note both groups were then offered PRP and at 6 months 81% improvement was noted in all 20 patients combined. At 12 months minimum 93% improvement was noted. Blinding did not occur at IRB request, accounting in part of the very small control group. All had pain over medial or lateral epicondyle (14/15 lateral) and pain at the elbow with resistance of either resisted flexion or extension respectively. The number of patients that were able to be contacted was not mentioned. Nevertheless results were impressive. Noted is that a blinded clinical trial was approved and status of this is not clear.
A copy of the complete study on Tennis Elbow in PDF format is available here.
