Effectiveness of Feldenkrais Method Versus a Back School Program in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change of Visual analogue scale (VAS) from baseline to 12 weeks
研究概览
简要总结
The purpose of this study study is to determine whether the Feldenkrais method is effective on pain control, functional recovery and quality of life in patients with chronic low back pain by comparing it with a Back School program.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of chronic nonspecific low back pain for at least three months;
- •Subjects aged between 18 and 80 years.
排除标准
- •Presence of acute low back pain;
- •Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis);
- •CNS and/or PNS disorders;
- •Systemic inflammatory disease (eg rheumatoid arthritis);
- •Systemic infectious disease;
- •Neoplastic disease;
- •Previous Surgery;
- •Cognitive impairment;
- •Pregnancy.
研究组 & 干预措施
Feldenkrais
The Feldenkrais method is a self education method that uses the somatic sensory-motor learning to enhance the functions of people in daily life activities through the awareness of their motor habits and the experience of more efficient alternatives.
干预措施: Feldenkrais Method (Other)
Back School
The Back School teaches the patient, with theoretical and practical knowledge, how to defend his own back from the pain and how to prevent their disease, considering awareness and education as important parts of the therapeutic process .
干预措施: Back School (Other)
结局指标
主要结局
Change of Visual analogue scale (VAS) from baseline to 12 weeks
时间窗: baseline, 4 weeks, 12 weeks
It is based on a ten point scale, where 0 means no pain and 10 the greatest pain ever. It enables the patients to express their pain intensity as numerical values.
次要结局
- Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of McGill Pain Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Waddell Disability Index from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
研究者
Teresa Paolucci
medical director
University of Roma La Sapienza