Tui-na and Oral Chinese Medicine on KOA

NCT ID: NCT04492670

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2023-03-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tui-na

Intervention Type: PROCEDURE

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.

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

Intervention Type: DRUG

This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.

Tui-na

8 sessions of 20 minutes Tui-na for 4 weeks

Group Type: OTHER

Tui-na

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Herbal granules

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhixiu Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Chan KH, Ching JYL, Chan KL, Lau HY, Chu KM, Chan K, Pang HF, Wong LC, Chia CP, Zhang HW, Song T, Leung SB, Ng BFL, Lin ZX. Therapeutic effect of Duhuo Jisheng Decoction add-on Tui-na manipulation on osteoarthritis of knee: a randomized controlled trial. Chin Med. 2023 Jul 10;18(1):82. doi: 10.1186/s13020-023-00737-5.

Reference Type: DERIVED

PMID: 37424023 (View on PubMed)

Other Identifiers

KOA

Identifier Type: -

Identifier Source: org_study_id