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).
Tenderness was elicited over the lateral epicondyle, extending 2-3 centimeters distal to it over the ECRB and extensor digitorum tendons.
Pain in lateral elbow with resisted extension of wrist and middle finger
Pain in lateral elbow with forceful grasp
Normal ROM of elbow
Patients that are pregnant and lactating
Had any form of administration of non-steroidal inflammatory drugs during the past two weeks
Had received steroid injections during the past two months
Patients with severe comorbidities, for example, poorly regulated Diabetes Mellitus, coagulopathy, goiter, liver-kidney disease, acute-chronic inflammation and any malignancies
Parallel
Selected Traditional Chinese Medicine manipulation
Other interventionSelected TCM manipulation for LE will be perform with internal rotation of the humerus, shoulder abduction, full elbow extension, and neutral position forearm and wrist. The practitioner will stabilized the wrist of the patient with one hand and the humerus with another hand. An medial inversion with a high velocity and low amplitude thrust will be done towards the downward position of the patient. The above manipulation will be done for group B patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho. We have obtained a professional consultation from Mr. Chiu Wai Shun, a senior physiotherapist with 20 years of clinical practice. Mr. Chiu evaluated and approved Dr. Chow's method of performing the Mills manipulation for this trial.
Mill's Manipulation
Other interventionMill's manipulation will be performed with a sitting position of the patient. The affected extremity positioned 90∘ abduction with internal rotation of the humerus, forearm pronation and wrist flexion, which will be stabilized by the practitioner. The olecranon should face upward in this position. The practitioner should stabilize the patients shoulder and holding the olecranon with the another hand. A high velocity, low-amplitude thrust will be applied at the end of full extension of the elbow. The above manipulation will be done for group A patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho.
Patient Related Tennis Elbow Evaluation (PRTEE)
PTREE involved 15 items which is self-reported by the patient, in order to measure their perceived pain and disability. There are three aspects in the questionnaire, including pain with 5 items, difficulty in performing usual activities with 6 items and difficulties in performing specific activities with 4 items. For each item, a scale of 1 to 10 can be chosen, hence the total score has a range of 1 to 100. Higher score indicates higher level of disability. Other than the English version of PRTEE, a recognized Chinese translated version will also be used to facilitate the responds of Chinese-speaking participants.
Range of Motion measurement
ROM of forearm and wrist will be measured with a universal goniometer. A. Degree of forearm supination and pronation is tested. The patient is positioned with elbow flexion of 90∘, keeping the forearm next to the trunk, while the forearm should be unsupported. The goniometer will be positioned parallel to the humerus. The patients is then be asked to perform forearm supination and pronation as much as they could. The range of supination or pronation will be recorded. B. Degree of wrist flexion and extension will be tested. The patient is positioned with elbow flexion of 90∘ and forearm pronation. The goniometer is placed with the distal arm along the lateral side of the fifth metacarpal and the proximal arm placed along the lateral side of the triquetrum of forearm. The ROM will be recorded at the lateral view.
Pain Free Grip Force (PFGS) measurement
PFGS will be measured with a handgrip dynamometer. PFGS refers to the maximum amount of force generated by the patient before any pain is felt. The patient is positioned with elbow extension, forearm pronation and slight wrist extension. The patient will do 3 gripping with the dynamometer in total and the mean of the three trials will be used.
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