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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tui-na and oral Chinese medicine | Experimental | 8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks |
|
| Tui-na | Other | 8 sessions of 20 minutes Tui-na for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tui-na | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
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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,
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:
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| Name | Affiliation | Role |
|---|---|---|
| Zhixiu Lin, PhD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37424023 | Derived | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Du-Huo-Ji-Sheng-Tang (DHJST) | Drug | This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used. |
|
|
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
| at 2 weeks and 8 weeks |
| D012216 |
| Rheumatic Diseases |