Tui-na and Oral Chinese Medicine on KOA

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

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

  • Procedure: Tui-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.
  • Drug: Du-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.

Arms, Groups and Cohorts

  • Experimental: Tui-na and oral Chinese medicine
    • 8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks
  • Other: Tui-na
    • 8 sessions of 20 minutes Tui-na for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
    • Time Frame: 4 weeks
    • to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96

Secondary Measures

  • EQ-5D-EL questionnaire
    • Time Frame: 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)
    • Time Frame: at 2 weeks and 8 weeks
    • to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Lin Zhixiu, Associate professor – Chinese University of Hong Kong
  • Overall Official(s)
    • Zhixiu Lin, PhD, Principal Investigator, Chinese University of Hong Kong

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