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

NCT07843771 | Not Yet Recruiting DMC

• 1 other identifier: REC/25-26/0404
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

To Evaluate the Efficacy and Safety of Selected TCM Elbow Manipulation in Treating; Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 4

Secondary Outcomes (2)

• Range of Motion measurement

  Baseline, week 4

• Pain Free Grip Force (PFGS) measurement

  Baseline, week 4

Study Arms (2)

Group A: Treatment with Selected TCM manipulation

EXPERIMENTAL

Selected 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.

Other: Selected Traditional Chinese Medicine manipulation

Group B: Treatment with Mill's Manipulation as the control

EXPERIMENTAL

Mill'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.

Other: Mill's Manipulation

Interventions

Selected Traditional Chinese Medicine manipulation OTHER

Selected 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.

Group A: Treatment with Selected TCM manipulation

Mill's Manipulation OTHER

Mill'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.

Group B: Treatment with Mill's Manipulation as the control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pain reproduced with resisted isometric contraction of wrist extensors during loaded test
• Absence of numbness and tingling at forearm, hand and fingers
• Absence of neck pain and stiffness
• Age 18 to 65
• Pain duration of more than 4 weeks with local tenderness near the lateral epicondyle
• Obtain a positive result in either Cozens Test or Mills' Test.

You may not qualify if:

• 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
• Infected or ulcerated skin around the lateral epicondylitis
• Had received any physical therapy treatment during the past two months
• Had received acupuncture during the past two weeks
• History of elbow surgery, fracture (distal humerus fracture, olecranon fractures and radial head and neck fractures), dislocation, infection, inflammation, tumor, rapidly progressive neurological deficit, neurovascular compromised and compartment syndrome
• Presence of osteoporosis

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok, Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (22)

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MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Central Study Contacts

Ying Ching Chan

CONTACT

97259392; 22229264@life.hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 28, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)