The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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
干预措施: Tui-na (Procedure)
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
干预措施: Du-Huo-Ji-Sheng-Tang (DHJST) (Drug)
Tui-na
8 sessions of 20 minutes Tui-na for 4 weeks
干预措施: Tui-na (Procedure)
结局指标
主要结局
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: 4 weeks
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
次要结局
- EQ-5D-EL questionnaire(8 weeks)
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC)(at 2 weeks and 8 weeks)
研究者
Prof. Lin Zhixiu
Associate professor
Chinese University of Hong Kong