The efficacy of prolotherapy for lateral epicondylosis: a pilot study.

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.