Randomised clinical trial to evaluate the effect of prolotherapy (Prt) injections and physiotherapy consisting of Mulligan's MWM and exercise (P/E) used singly and in combination, on pain and function in patients with lateral epicondylalgia (Tennis Elbow).

ABSTRACT Objective: Lateral epicondylalgia (LE, tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of LE are hypertonic glucose plus lignocaine injections (prolotherapy) and a physical therapist guided manual therapy/exercise program (PT). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with PT. Design: Single-blinded randomized clinical trial. Methods: 120 participants with LE of at least six weeks’ duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), PT (weekly for 4 sessions) or combined (prolotherapy+PT). Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.’ Analysis was by intention-to-treat. Results: 88% completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The PT group exhibited greater reductions in PRTEE at 6 and 12 weeks than the prolotherapy group. Duration of illness of less than 6 months predicted success rate, regardless of treatment. Conclusions: Pain and function measures improved substantially in all groups, more quickly in the PT group than prolotherapy group. The addition of prolotherapy to PT did not influence the rate of recovery.