Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change from baseline in average pain intensity in previous week
研究概览
简要总结
A randomized controlled trial for patients with chronic low back pain with two treatment arms and one waiting list control group. Primary outcome is pain intensity on VAS.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion
- •Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months.
排除标准
- •Regular own exercise practice for the treatment of back pain (including yoga and other interventions)
- •Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks
- •Acute disc herniation (diagnosed within the last 3 months)
- •Congenital deformities of the lumbar spine
- •Rheumatoid arthritis
- •Fibromyalgia
- •Ankylosing spondylitis
- •Severe comorbidities
- •Pregnancy/lactation
- •Current participation in another clinical trial
研究组 & 干预措施
Manual Therapy/Exercises
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
干预措施: Manual Therapy/Exercises (Behavioral)
Physiotherapy/Back School
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
干预措施: Physiotherapy/Back School (Behavioral)
Waiting List
Study arm 3 consists of a waiting list control group, combined with the offer to participate in one of the above mentioned interventions after 6 months.
结局指标
主要结局
Change from baseline in average pain intensity in previous week
时间窗: 3 months
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
次要结局
- Change from baseline for back pain specific disability(3 months, 6 months)
- Change from baseline for work productivity(3 months, 6 months)
- Change from baseline for pain self-efficacy(3 months, 6 months)
- Change from baseline in pain medication use in the previous week(3 months, 6 months)
- Change from baseline for health related quality of life(3 months, 6 months)
- Change from baseline in average pain intensity in previous week(6 months)
- Change from baseline in pain bothersomeness in previous week(3 months, 6 months)
- Change from baseline for anxiety and depression(3 months, 6 months)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany