Comparison of Cost and Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 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
Perform a cost-utility analysis in patients with chronic low back pain through electroanalgesia treatment and exercises administered by telemedicine program versus face-to-face program
详细描述
A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the cost- effectiveness of a face-to- face rehabilitation program vs a telemedicine program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain ≥ 3 months.
- •Age between 30 and 67 years old.
- •Not being receiving physical therapy.
排除标准
- •Presence of lumbar stenosis.
- •Diagnosis of spondylolisthesis.
- •Diagnosis of fibromyalgia.
- •Treatment with corticosteroids or oral medication in recent weeks.
- •History of spine surgery.
- •Contraindication of analgesic electrical therapy.
- •Have previously received a treatment of electrical analgesia or exercise.
- •Central or peripheral nervous system disease.
结局指标
主要结局
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
时间窗: At baseline, at 8 weeks 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.Ranging from 0 points- better to 24 points- worse disability
次要结局
- Change from baseline in disability. Oswestry Low Back Pain Disability Idex.(At baseline, at 8 weeks and at 6 months.)
- Change from baseline in direct medical costs(At baseline, at 8 weeks and at 6 months)
- Change from baseline direct non-medical costs(At baseline, at 8 weeks and at 6 months)
- Change from baseline on Quality of Life. SF-36 Health questionnaire.(At baseline, at 8 weeks and at 6 months)
- Change from baselina in range of motion(At baseline, at 8 weeks and at 6 months)
- Change from baseline in pain intensity. Visual analogue scale.(At baseline, at 8 weeks and at 6 months)
- Change from baseline in lumbar mobility flexion.(At baseline, at 8 weeks and at 6 months)
- Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, at 8 weeks and at 6 months)
- Change from Mcquade Test(At baseline, at 8 weeks and at 6 months)
- Change from baseline in indirect non-medical costs(At baseline, at 8 weeks and at 6 months)
- Changes from baseline in Lumbar electromyography.(At baseline, at 8 weeks and at 6 months)
- Change from baselina in lumbar segmental mobility(At baseline, at 8 weeks and at 6 months)
研究者
Adelaida María Castro-Sánchez
Principal Investigator
Universidad de Almeria