Clinical trial NCT04492670: Tui-na and Oral Chinese Medicine on KOA
Official title: The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis, Tui-na, Chinese medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 4 weeks
Secondary outcomes:
measure: EQ-5D-EL questionnaire
timeFrame: 8 weeks
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: at 2 weeks and 8 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zhixiu Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: