Tui-na and Oral Chinese Medicine on KOA
July 23, 2026 updated by: Prof. Lin Zhixiu, Chinese University of Hong Kong
The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial
The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA.
This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for Chinese medicine practitioner (CMP) investigators assessments.
The Western Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed and filled up at different timepoints.
The treatment group will receive both Tui-na and study medication and the wait-list control group will receive Tui-na alone.
CMPs will provide consultation under Chinese medicine theory.
Study medication compliance and adverse events will also be assessed at each visit.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Chinese University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- of either gender (female must have either sterilization done or menopause)
- ≥50years of age
meet the criteria of KOA according to the American College of Rheumatology
- Knee pain, and
Any 4 of the following,
- ≥ 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovium
- Osteophytes (Radiographic findings)
- with WOMAC score ≥ 39
- with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)
Exclusion Criteria:
- Known knee pain caused by infection, malignant or autoimmune diseases
- Knee surgery or arthroscopy in the past year
- Chondroprotective or intra-articular injection in the past 4 months
- Systemic corticoid treatment in the past 4 months
- Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs
- Subject with uncontrolled hypertension
- Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks
- Known history of mental disorder
- Known history of serious acute organic disease
- Renal or liver function impairment
- Known allergy to or have drug interaction with the study herb
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tui-na and oral Chinese medicine
8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks
|
For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience.
The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.
This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
Other Names:
|
|
Other: Tui-na
8 sessions of 20 minutes Tui-na for 4 weeks
|
For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience.
The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 4 weeks
|
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EQ-5D-EL questionnaire
Time Frame: 8 weeks
|
to assess health-related quality of life, one part is descriptive has 5 response level, the other part is VAS which ranges from 0 to 100
|
8 weeks
|
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: at 2 weeks and 8 weeks
|
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
|
at 2 weeks and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhixiu Lin, PhD, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2020
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (Actual)
July 30, 2020
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.