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
- 1
- 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.
研究组 & 干预措施
Face-to Face rehabilitation program
Electroanalgesia therapy and the McKenzie exercise protocol will be applied by six therapists with more than 10 years of experience. This program will be developed in the rehabilitation service of the study health centers. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions
干预措施: Face-to-Face Rehabilitation program (Other)
Telemedicine Program
It consists in a support system for the treatment of chronic low back pain based on web technologies. The system can register a subject and provide a treatment of electroanalgesia and exercise through the Mckenzie method. Video applications of electroanalgesia and exercises will be shown to patients who use their computer or mobile device to access the platform through the Internet. The treatments will be recommended by the system based on the database that is configured to accommodate the application of electroanalgesia and McKenzie exercises based on the diagnosis according to the McKenzie method.patients will perform the treatment 3 times per week, for 8 weeks, with a total of 24 sessions
干预措施: Telemedicine program (Other)
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