Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised on Pain, Disability, Quality of Life and Kinesiophobia in Patients With Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
This study compares the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program on pain, disability, quality of life and kinesiophobia in patients with non-specific low back pain.
详细描述
Low back pain is one of the most common problems of population, being a priority for health systems. It has got a high prevalence and recurrence, affecting in a social and economic way, and, it is one of principal causes of laboral absenteism. A randomized clinical trial will be conducted comparing a supervised physical therapy rehabilitation program vs a non supervised rehabilitation program.
Objective
to compare the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program in patients with non-specific low back pain.
Methods: Sixt-four subjects with chronic non-specific low back pain will be assigned to supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5 sessions/week). Outcomes measures will be the following: disability, pain intensity, fear of movement, quality of life, McQuade Test, and lumbar mobility flexion.
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)
盲法说明
Single-Blind
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
- •Chronic non-specific low back pain persisting ≥ 3 months.
- •Age between 18 and 65 years.
- •A score ≥ 4 in Roland Morris Disability Questionnaire.
- •Not currently receiving physical therapy.
排除标准
- •Presence of lumbar stenosis.
- •Presence of clinical signs of radiculopathy.
- •Diagnosis of spondylolisthesis.
- •Diagnosis of fibromyalgia.
- •Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
- •A history of spinal surgery.
- •Central or peripheral nervous system disease.
研究组 & 干预措施
Supervised Rehabilitation program
It will be consist in a supervised exercise program by physical therapist, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility
干预措施: Supervised exercise program (Other)
Nonsupervised rehabilitation program
It will consist in an exercise program for home, nonsupervised, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility. The patients will perform an exercise program at home.
干预措施: Non supervised exercise program (Other)
结局指标
主要结局
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
时间窗: at baseline,immediate post-treatment and at 6 months
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities
次要结局
- Change from baseline in disability. Oswestry Low Back Pain Disability Index.(At baseline, immediate post-treatment and at 6 months)
- Change from baseline in lumbar mobility flexion(at baseline, immediate post-treatment and at 6 months)
- Change from baseline in pain intensity (Visual Analogue Scale).(At baseline, immediate post-treatment and at 6 months)
- Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, immediate post-treatment and at 6 months)
- Change from Mcquade Test(at baseline, immediate post-treatment and at 6 months)
- Change from baseline on Quality of Life.(At baseline, immediate post-treatment and at 6 months)
研究者
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria