Phase 1 Study of Massage Therapy for Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
研究概览
简要总结
The purpose of this study is to determine whether massage is effective in the treatment of low back pain and to optimize clinical therapeutic schedule of massage for low back pain.
详细描述
Chronic low back pain is a prevalent condition among adults. Large majority of the population suffer from Chronic low back pain in their lifetime. At present, there is still no standard treatment for chronic low back pain. Massage is commonly chose and widely used by sufferer as a complement to conventional treatment. However, its effectiveness is still not convinced. This trial is designed to assess the effectiveness of massage for chronic low back pain.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance of the diagnostic criteria of low back pain;
- •Age between 20 and 55 years old;
- •Not taking hormone drugs or antirheumatic drugs within the latest 2 months;
- •No allergy history of hormone drugs Pain medicine;
- •volunteer participation and signing an informed consent in writing.
排除标准
- •Being pregnant or during lactation;
- •Having suffered from serious psychiatric, neurologic, cardiovascular, respiratory, or renal illnesses, and so forth;
- •Severe neurological deficits caused by severe lumbar disc protrusion, and operation indications;
- •Receiving message therapy in past 3 months for releasing low back pain.
研究组 & 干预措施
Massage
To treat low back pain with massage
干预措施: Massage (Other)
Ibuprofen
Medicine control group
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
时间窗: At baseline, 4th, 6th, 8th week
to assess the recovery of back function
次要结局
- Japanese Orthopaedic Association Scores(At baseline, 4th, 6th, 8th week)
- McGill pain questionnaire(At baseline, 4th, 6th, 8th week)