Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, Tui-na, Chinese medicine
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.
Interventions
PROCEDURETui-na
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.
DRUGDu-Huo-Ji-Sheng-Tang (DHJST)
This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. of either gender (female must have either sterilization done or menopause) 2. ≥50years of age 3. 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) 4. with WOMAC score ≥ 39 5. with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)
Exclusion criteria
1. Known knee pain caused by infection, malignant or autoimmune diseases 2. Knee surgery or arthroscopy in the past year 3. Chondroprotective or intra-articular injection in the past 4 months 4. Systemic corticoid treatment in the past 4 months 5. Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs 6. Subject with uncontrolled hypertension 7. Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks 8. Known history of mental disorder 9. Known history of serious acute organic disease 10. Renal or liver function impairment 11. Known allergy to or have drug interaction with the study herb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORZhixiu Lin, PhD
Chinese University of Hong Kong
Outcome results
None listed