Tui-na and Oral Chinese Medicine on KOA

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Tui-na
* Drug: Du-Huo-Ji-Sheng-Tang (DHJST)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tui-na and oral Chinese medicine<br>8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks | Procedure: Tui-na<br>* 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.<br>Drug: Du-Huo-Ji-Sheng-Tang (DHJST)<br>* This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.<br>* Other names: Herbal granules;|
| Other: Tui-na<br>8 sessions of 20 minutes Tui-na for 4 weeks | Procedure: Tui-na<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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 | 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) | to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96 | at 2 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, Tui-na, Chinese medicine