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Tui-na and Oral Chinese Medicine on KOA

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tui-na
Du-Huo-Ji-Sheng-Tang (DHJST)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Tui-na, Chinese medicine

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tui-na and oral Chinese medicine

Tui-na

Arm Description

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

8 sessions of 20 minutes Tui-na for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

EQ-5D-EL questionnaire
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)
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96

Full Information

First Posted
July 28, 2020
Last Updated
June 21, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04492670
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Tui-na, Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tui-na and oral Chinese medicine
Arm Type
Experimental
Arm Description
8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks
Arm Title
Tui-na
Arm Type
Other
Arm Description
8 sessions of 20 minutes Tui-na for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
Tui-na
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Du-Huo-Ji-Sheng-Tang (DHJST)
Other Intervention Name(s)
Herbal granules
Intervention Description
This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
EQ-5D-EL questionnaire
Description
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
Time Frame
8 weeks
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Time Frame
at 2 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: of either gender (female must have either sterilization done or menopause) ≥50years of age 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) with WOMAC score ≥ 39 with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission) Exclusion Criteria: Known knee pain caused by infection, malignant or autoimmune diseases Knee surgery or arthroscopy in the past year Chondroprotective or intra-articular injection in the past 4 months Systemic corticoid treatment in the past 4 months Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs Subject with uncontrolled hypertension Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks Known history of mental disorder Known history of serious acute organic disease Renal or liver function impairment Known allergy to or have drug interaction with the study herb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiu Lin, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Tui-na and Oral Chinese Medicine on KOA

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