Tui-na and Oral Chinese Medicine on KOA
- Conditions
- Knee Osteoarthritis
- Interventions
- Procedure: Tui-naDrug: Du-Huo-Ji-Sheng-Tang (DHJST)
- Registration Number
- NCT04492670
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
-
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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tui-na and oral Chinese medicine Tui-na 8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks Tui-na and oral Chinese medicine Du-Huo-Ji-Sheng-Tang (DHJST) 8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks Tui-na Tui-na 8 sessions of 20 minutes Tui-na for 4 weeks
- Primary Outcome Measures
Name Time Method The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 4 weeks to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
- Secondary Outcome Measures
Name Time Method EQ-5D-EL questionnaire 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
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 2 weeks and 8 weeks to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Trial Locations
- Locations (1)
The Chinese University of Hong Kong
🇭🇰Hong Kong, Hong Kong