A Study Protocol Randomised Feasibility Trial Comparing a Home Rehabilitation Program Versus e-Health Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline the acceptability and demand of the e-Health intervention for patients and physiotherapists in comparison with the home rehabilitation program for the optimization of their design, development and delivery
研究概览
简要总结
The aim of this randomized controlled trial is to evaluate the feasibility and effectiveness of providing an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the McKenzie Method for patients with chronic low back pain in primary care, compared with the same home rehabilitation program but without the support of an electronic 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 effectiveness of a home rehabilitation program vs a web platform 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.
- •Score ≥ 4 points on the Roland Morris Disability Questionnaire.
- •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.
- •Agoraphobia
结局指标
主要结局
Change from baseline the acceptability and demand of the e-Health intervention for patients and physiotherapists in comparison with the home rehabilitation program for the optimization of their design, development and delivery
时间窗: At baseline, immediate post-treatment and 6 months
The extent to which participants who have received the intervention through a web application consider that the content and support materials (web application and initial learning sessions) are appropriate and satisfactory to obtain the expected results.The extent to which the physiotherapists who have administered the intervention consider that the training, content and support materials are appropriate.Brief questionnaire developed for this trial\* 10-items Patients rate their acceptability and demand of treatment received and trial participation, including the burden of outcome measure completion. Measured with 10-point numeric rating scales ranging from not at all satisfactory to extremely satisfactory
Change from baseline the feasibility of the trial procedures
时间窗: At baseline, immediate post-treatment and 6 months
The extent to which participants believe that their eligibility, outcome measures, follow-up and intervention by the physiotherapist have been satisfactory. The extent to which physiotherapists who have participated in the trial consider recruitment, outcome measures, evaluation follow-ups and appropriate and satisfactory intervention procedures.Brief questionnaire developed for this trial\* 4-items Measured with 10-point numeric rating scales ranging from not at all helpful to extremely helpful
Change from baseline adaptation of the e-Health intervention and the trial procedures for to randomized clinical trial definitive
时间窗: At baseline, immediate post-treatment and 6 months
The extent to which the content of the e-health intervention, support materials and learning classes should be modified to improve their acceptability and implementation for a future definitive trial The extent to which recruitment, follow-up procedures and the number and outcome measures should be modified during / at the end of the trial to improve its acceptability and implementation for a definitive future trial.Brief questionnaire developed for this trial\* 11-items Measured using yes/no responses
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 lumbar mobility flexion.(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 baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, at 8 weeks and at 6 months)
- Change from baselina in range of motion and lumbar segmental mobility(At baseline, at 8 weeks and at 6 months)
- Change from baseline in Roland Morris Disability Questionnaire(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 Mcquade Test.(At baseline, at 8 weeks and at 6 months)
- Changes from baseline in Lumbar electromyography.(At baseline, at 8 weeks and at 6 months)
研究者
Adelaida María Castro-Sánchez
Principal Investigator
Universidad de Almeria