Combined multimodal therapies for chronic tennis elbow: pilot study to test protocols for a randomized clinical trial.

OBJECTIVE: The objective of this project was to develop and test protocols for a randomized clinical trial (RCT) of 2 multimodal package therapies for chronic lateral epicondylitis.

METHODS: Six participants were enrolled after case review and randomized to 1 of 2 groups (4 in group A and 2 in group B). Group A had high-velocity low-amplitude manipulation, high-voltage pulse galvanic stimulation, counterforce bracing, ice, and exercises, whereas group B had ultrasound, counterforce bracing, and exercise. Both groups had 12 weeks of active care and instructed to restrict usage of the affected elbow. Participants filled out a visual analog scale and the Patient Rated Tennis Elbow Evaluation every week. The pain-free grip strength test was measured at baseline, and at the end of the third, sixth, ninth, and twelfth visits.

RESULTS: One participant in group A dropped out before the end of care. Both groups demonstrated changes in all of the outcome variables from the baseline to the end point (12 weeks) of treatment. Sample size for a larger future randomized clinical trial was calculated as n = 246 participants.

CONCLUSION: The pilot study demonstrated that the study design is feasible and that patients could be recruited for a 12-week trial of multimodal treatment. A larger trial is warranted in a multicenter setting to detect differences in the effects of these treatment strategies.