Effect of the Implementation of Telerehabilitation-based Exercises Compared to the Standard Use of Exercise Dossier and Intervention Diary in a Home Therapeutic Exercise Intervention in Patients With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
The objective of the study is to compare the effect of a telerehabilitation-based exercise program, versus a home therapeutic exercise program scheduled through a dossier and an exercise diary, with respect to disability (measured using the OSWESTRY questionnaire) and other variables (range of motion, strength, fatigue, histological changes, pain, medication intake, psychosocial factors and adherence), in patients with low back pain.
详细描述
The objective of the study is to compare the effect of a telerehabilitation-based exercise program, versus a home therapeutic exercise program scheduled through a dossier and an exercise diary, with respect to disability (measured using the OSWESTRY questionnaire) and other variables (range of motion, strength, fatigue, histological changes, pain, medication intake, psychosocial factors and adherence), in patients with low back pain.
This randomized controlled trial has a parallel design, with two groups. Both groups will complete an 8-week home exercise program that includes flexibility and strength exercises. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. In the case of the experimental group, the program will be carried out with the support of the TRAK computer tool (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows investigators/clinicians to keep a record of the sessions. In the case of the control group, the program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted. In both groups, as an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively.
The exercise program includes flexibility and strength exercises, each made up of three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.
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
- •Nonspecific subacute or chronic low back pain
排除标准
- •Neuropathic pain
- •Pain below the knees
- •Pain in legs with tingling, sensation of current or sensory alterations
- •Positive neurological tests. Lack of strength, sensitivity or altered reflexes
- •Canal stenosis
- •Nociplastic pain (fibromyalgia, generalized pain, emotional lability, affective and cognitive implications)
- •Previous lumbar surgery
- •Specific pathology (rheumatic, spondylolisthesis, oncological, fractures...)
- •Pregnancy
- •Performing medium-high intensity exercise of more than 100 minutes a week
- •Pathology that prevents exercise (decompensated cardiac pathology, decompensated respiratory pathology, significant mobility difficulties...)
- •Lack of digital skills
- •Visual problems that prevent exercise with the phone screen
研究组 & 干预措施
Telerehabilitation-based exercises
Home therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation
干预措施: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK (Other)
Standard home-based exercise
Home therapeutic exercise program scheduled through a dossier and an exercise diary
干预措施: Standard home-based exercise (Other)
结局指标
主要结局
Disability
时间窗: 8 weeks measurement (post intervention)
Disability measured using the Oswestry Disability Index
次要结局
- Range of movement (Schober score)(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Disability(Baseline; 32 weeks measurement (24 weeks post intervention))
- Extensor low back muscle strength(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Muscle thickness (low back extensor muscles)(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Low Back Pain(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Medication intake(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Kinesiphobia(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Depression(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Range of movement (Finger floor distance test)(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Fear Avoidance Beliefs(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Fear Avoidance Components(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Muscle thickness (transversus abdominis)(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
- Adherence(Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention))
研究者
Rodrigo Martín-San-Agustin
Assistant Professor of Physiotherapy
University of Valencia