Effectiveness of a Craniosacral Therapy Program on Disability, Quality of Life, Autonomic Nervous System and Oxidative Stress Indicators in Chronic Low Back Pain: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change for the Roland Morris Disability Questionnaire
研究概览
简要总结
The purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.
详细描述
Design: Randomized clinical trial. Objective: to determine the effectiveness of a craniosacral therapy program on disability, quality of life, autonomic nervous system, body mass, hormonal indicators, spinal projection, and oxidative stress indicators in patients with chronic low back pain.
Participants: Seventy patients with chronic non-specific low back pain will be randomly assigned to an experimental and control group.
Intervention: For 10-week, the experimental group will undergo treatment comprising 10 sessions (1/week) of a craniosacral therapy program with ten techniques, and the control group will receive only one craniosacral technique.
Main Outcome Measures: disability, quality of life, biochemical estimation interstitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nervous system,and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain for > 3 months
- •Score > 4 on the Roland Morris Disability questionnaire
- •No undergoing another physical therapy treatment
排除标准
- •Clinical signs of radiculopathy
- •Presence of lumbar stenosis
- •Fibromyalgia
- •Spondylolisthesis
- •History of spinal surgery
- •Treatment with corticosteroids in the past two weeks
- •Disease of the central or peripheral nervous system
研究组 & 干预措施
Craniosacral Therapy Program
A program of 10 craniosacral therapy techniques
干预措施: Craniosacral Therapy Program (Other)
One technique of craniosacral therapy
Decompression L5-S1.
干预措施: One technique of craniosacral therapy (Other)
结局指标
主要结局
Change for the Roland Morris Disability Questionnaire
时间窗: At baseline, 10 weeks and 15 weeks
The Roland Morris Disability Questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability
次要结局
- Change for the Lifestyle indicators(At baseline, 10 weeks and 15 weeks)
- Change on Quality of Life(At baseline, 10 weeks and 15 weeks)
- Change on Neural Network Analysis(At baseline, 10 weeks and 15 weeks)
研究者
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria