Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
研究概览
简要总结
Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. Tuina therapy has been used and showed effectiveness and safety for pain relief and disability for the patients with musculoskeletal disorders for years in China. Though it is regarded that the Traditional Chinese medicine (TCM) Tuina therapy is similar to the modern manual therapies, the modalities of TCM tuina therapy are different and effect maybe equal to or more better than the modern manual therapy in clinic. However, little evidence exists that Tuina benefits the KOA. The investigators will do this in a randomized, parallel, active controlled study to observe whether TCM Tuina is more beneficial to KOA than the physical manual therapy, which has been considered an effective and standard care for KOA.
详细描述
Patients will be randomly allocated to one of two groups. In the Chinese Tuina group (group CTG), patients will receive the traditional Chinese Tuina therapy (including rolling, grasping, scratching, pressing, acupressure or pushing) on the basis of KOA health education and home-exercise. Patients in the Physical Manual group (group PMG) will receive the modern physical manual therapy (including joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching, range of motion and strength training) on the basis of KOA health education and home-exercise. Assessments will be conducted at baseline and 4 and 16 weeks after randomization.
It is expected that the interventions will alleviate the sufferings of the patient. The risks of participation are minimal. Occasionally, tuina can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects happen during and after Tuina or manual treatment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are randomly divided into Chinese Tuina group and Physical Manual group at a ratio of 1:1, only knowing that they will receive the manual therapies. The assessor, data manager and statistician will not participate in the randomized process and the treatment and share any information with each other.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of KOA;
- •Age 40-75 years;
- •KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
- •NRS score of pain at least more than 4 points;
- •Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on both legs, the heavier leg is selected for study.
排除标准
- •Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
- •Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
- •Oral administration of hormones within 3 month, intra-articular injection within 6 months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1 year.
- •Severe acute/chronic organic or mental diseases;
- •Pregnant women, pregnant and lactating women;
- •Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
- •Device support treatment after knee osteoarthritis disability;
- •Participation in another clinical study in the past 3 months;
- •History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
- •Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
结局指标
主要结局
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
时间窗: Change from baseline at 4 weeks
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
次要结局
- Change in Timed Up and Go Test Time(Change from baseline at 4 weeks)
- Change in 12-item Short Form Health Survey (SF-12)(Change from baseline at 4 weeks, 8 weeks and 16 weeks)
- Change in 30 second time chair rise test(Change from baseline at 4 weeks)
- Change in One Leg Standing Test(Change from baseline at 4 weeks)
- Change in Patient Global Assessment (PGA)(Change from baseline at 4 weeks, 8 weeks and 16 weeks)
- Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Change from baseline at 8 weeks and 16 weeks)
- Change in Numeric Knee Pain Rating Scale(Change from baseline at 4 weeks, 8 weeks and 16 weeks)
- OARSI Responder Criteria(At weeks 4 after randomisation.)
- Blinding assessment(At weeks 4 after randomisation.)
- Credibility/Expectancy Questionnaire(About 5 min after the first treatment)
- Rescue medicine(At weeks 4, 8 and 16 after randomisation.)
- Adverse events(At weeks 4 after randomisation.)
研究者
Changhe Yu
Principal Investigator
Beijing University of Chinese Medicine