Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
No randomized trials have tested the effectiveness of acupuncture as a supplement to rehabilitation after total knee replacement. Studies from related fields, however, have shown reduction of symptoms as a result of acupuncture treatment in patients with knee pain caused by severe osteoarthritis in the knee. Furthermore, studies have reported that the need of pain medication was lower when acupuncture treatment was performed immediately after knee surgery.
The aim of this study is to test whether acupuncture can reduce pain and improve disability as a supplement to rehabilitation after total knee replacement.
One hundred and seventy patients will be allocated by drawing lots to either a treatment group receiving exercise therapy and acupuncture or a group receiving exercise therapy alone. Treatment will start 3 weeks after surgery at the latest.
Outcome of treatments will be measured at completion of treatment and at 3 months follow-up by pain- and disability questionnaires as well as the recording of walking capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemi- or total knee arthroplasty.
- •18 - 70 years of age.
排除标准
- •Concurrent diseases that compromises treatment, i.e.hip disease, rheumatoid arthritis, migraine).
- •Bleeding disorders.
- •Heart disease or use of pacemaker.
- •Lack of patient cooperation, i.e. psychological disorders, alcoholism, problems with language).
- •Infection.
- •Exclusion criteria during intervention:
- •Infection.
- •Cicatrice-burst.
研究组 & 干预措施
Acupuncture
Acupuncture in combination with exercise therapy
干预措施: Acupuncture (Procedure)
exercises
Coordination, mobilizing, endurance, strength
干预措施: exercises (Procedure)
结局指标
主要结局
pain
时间窗: 3 months after treatment
次要结局
- disability(3 months after treatment)
研究者
Tom Petersen
Physical Therapist
Back and Rehabilitation Center, Copenhagen