Tui-na and Oral Chinese Medicine on KOA

The Chinese University of Hong Kong

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Drug: Du-Huo-Ji-Sheng-Tang (DHJST); Procedure: Tui-na

Study type: Interventional

Funder types: Other

Identifiers

NCT04492670

KOA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Tui-na and oral Chinese medicine

Experimental group

Description:

8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks

Treatment:

Procedure: Tui-na

Drug: Du-Huo-Ji-Sheng-Tang (DHJST)

Tui-na

Other group

Description:

8 sessions of 20 minutes Tui-na for 4 weeks

Treatment:

Procedure: Tui-na