Tui-na and Oral Chinese Medicine on KOA

June 21, 2022 updated by: Prof. Lin Zhixiu, Chinese University of Hong Kong

The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Herbal granules
Other: Tui-na
8 sessions of 20 minutes Tui-na for 4 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
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
at 2 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Zhixiu Lin, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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