Tui-na and Oral Chinese Medicine on KOA

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04492670
• Other study ID #: KOA
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: March 2023

Study information

• Verified date: June 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	8 weeks
Secondary	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	at 2 weeks and 8 weeks