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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.