Efficacy and Safety of Selected Traditional Chinese Medicine Elbow Manipulation Versus Mill's Manipulation as Control for Lateral Epicondylitis

Background: Lateral epicondylitis (LE), also referred to as lateral elbow tendinopathy and tennis elbow, is commonly seen clinically as an orthopedic disease. Joint manipulations is a common LE treatment, which mainly decrease pain and increases range of motion (ROM). This greatly improve the quality of life of LE patients. The selected Traditional Chinese Medicine (TCM) manipulation is created by Prof. Ng Zhong Neng and clinically used in treating LE for more than 20 years. To date, there is no statistical demonstration regarding the safety and effectiveness of this technique. Consequently, this clinical trial is designed to provide the first systematic evaluation of the technique's efficacy and safety. Objective: To evaluate the efficacy and safety of selected TCM elbow manipulation in treating LE. Methods: A clinical trial will enroll 40 eligible patients diagnosed with LE who meet the inclusion criteria. They will be randomized into two groups, having 20 participants in each group. Group A will receive an exercise program and a manipulation treatment of Mill's manipulation. Meanwhile, Group B will receive the same exercise program and the selected TCM manipulation. Patient Related Tennis Elbow Evaluation (PRTEE), ROM of wrist and forearm, and pain free grip strength (PFGS) of the affected elbow will be evaluated at the beginning and after the last of intervention in this clinical trial. Treatment effect and sequence effect will be analyze with a linear-mixed effect model by Jamovi (2.7.17).