Abstract
BackgroundLateral epicondylalgia (tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of lateral epicondylalgia are hypertonic glucose plus lignocaine injections (prolotherapy) and a physiotherapist guided manual therapy/exercise program (physiotherapy). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with physiotherapy.MethodsUsing a single-blinded randomised clinical trial design, 120 participants with lateral epicondylalgia of at least 6 weeks’ duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), physiotherapy (weekly for 4 sessions) or combined (prolotherapy+physiotherapy). The 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.ResultsEighty-eight percent 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 physiotherapy group exhibited greater reductions in PRTEE at 12 weeks than the prolotherapy group (p = 0.014).ConclusionThere were no significant differences amongst the Physiotherapy, Prolotherapy and Combined groups in PRTEE and global impression of change measures over the course of the 12-month trial.Trial registrationACTRN12612000993897.
Highlights
Whilst there is controlled trial evidence that physiotherapy-directed treatment is more effective than usual care [5, 6] and that prolotherapy injections are more effective than placebo injections [8], physiotherapy-directed treatment and prolotherapy injections have never been directly compared in a pragmatic trial
The outcome assessor correctly guessed group allocation for 31 participants (26%) a guess rate that is less than the random chance rate for three groups (33%)
Reduction in Patient Rated Tennis Elbow Evaluation (PRTEE) scores was significantly greater at 12 weeks (p = 0.01) for Physiotherapy compared to Prolotherapy (Table 2; Fig. 2)
Summary
Lateral epicondylalgia (LE; tennis elbow) is a common, debilitating and expensive musculoskeletal pain condition primarily of the extensor carpi radialis brevis at the lateral humeral epicondyle [1].While it is generally considered to be self-limiting at six to 24 months [2], up to 10% of patients developA physiotherapy program consisting of manual therapy techniques and therapeutic exercise has previously demonstrated clinical effectiveness in the short- and longterm compared to wait-and-see (or placebo injection) and corticosteroid injection [5, 6].Prolotherapy is an injection therapy that uses a hypertonic irritant solution of glucose with lignocaine, which is thought to stimulate healing and strengthening of degenerative tendon tissue by inciting inflammationYelland et al BMC Musculoskeletal Disorders (2019) 20:509 followed by collagen deposition and remodelling [7, 8]. Whilst there is controlled trial evidence that physiotherapy-directed treatment is more effective than usual care [5, 6] and that prolotherapy injections are more effective than placebo injections [8], physiotherapy-directed treatment and prolotherapy injections have never been directly compared in a pragmatic trial This is a question of considerable interest to clinicians choosing from the available active treatments and for the patients and health funds who pay for them. Two treatments thought to address the pathology of lateral epicondylalgia are hypertonic glucose plus lignocaine injections (prolotherapy) and a physiotherapist guided manual therapy/exercise program (physiotherapy). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with physiotherapy
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