Benefits of Craniosacral Therapy in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Roland-Morris Disability Questionnaire (RMQ)
研究概览
简要总结
The purpose of the current randomized clinical trial was to analyze the effectiveness of craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid in individuals with chronic low back pain.
详细描述
Objective
To analyze the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with chronic low back pain.
Design: A single blinded randomized controlled trial. Setting: Clinical setting. Subjects: Sixty-four patients (42 females) with chronic low back pain. Interventions: Patients were randomly assigned to an experimental group (craniosacral therapy group) or a control group (classic massage group).
Main measures: Self-reported disability (Roland Morris Disability Questionnaire - primary outcome; and Oswestry Disability Index), pain intensity (a 10-point Numerical Pain Rating Scale), scale of kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade Test), lumbar mobility in flexion, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid.
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
- •LBP for/over three months.
- •age between 18 and 65 years.
- •score equal or superior of four points on the Roland Morris Disability Questionnaire.
- •not currently receiving physical therapy.
排除标准
- •presence of lumbar stenosis
- •diagnosis of spondylolisthesis
- •diagnosis of fibromyalgia
- •treatment with corticosteroid or oral medication within the past two weeks
- •a history of spinal surgery
- •disease of the central or peripheral nervous system
结局指标
主要结局
Roland-Morris Disability Questionnaire (RMQ)
时间窗: Changes in 10 weeks and 14 weeks
It is one of the most used questionnaires for assessing disability due to LBP. This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to LBP including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
次要结局
- Oswestry Low Back Pain Disability Index (ODI).(10 weeks and 14 weeks)
- 10-point Numerical Pain Rating Scale(10 weeks and 14 weeks)
- Tampa Scale of Kinesiophobia (TSK)(10 weeks and 14 weeks)
- Isometric endurance of trunk flexor muscles(10 weeks and 14 weeks)
- Lumbar mobility in flexion(10 weeks and 14 weeks)
- Hemoglobin Oxygen Saturation(10 weeks and 14 weeks)
- Systolic Blood Pressure(10 weeks and 14 weeks)
- Diastolic Blood Pressure(10 weeks and 14 weeks)
- Hemodynamic (Cardiac Index)(10 weeks and 14 weeks)
- Insterticial Liquid Biochemical Estimation(10 weeks and 14 weeks)
研究者
Adelaida María Castro-Sánchez
Dr
Universidad de Almeria