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
Overview
- Phase
- N/A
- Intervention
- Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
- Conditions
- Low Back Pain
- Sponsor
- University of Valencia
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Disability
- Status
- Recruiting
- Last Updated
- 3 days ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Rodrigo Martín-San-Agustin
Assistant Professor of Physiotherapy
University of Valencia
Eligibility Criteria
Inclusion Criteria
- •Nonspecific subacute or chronic low back pain
Exclusion Criteria
- •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
Arms & Interventions
Telerehabilitation-based exercises
Home therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation
Intervention: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
Standard home-based exercise
Home therapeutic exercise program scheduled through a dossier and an exercise diary
Intervention: Standard home-based exercise
Outcomes
Primary Outcomes
Disability
Time Frame: 8 weeks measurement (post intervention)
Disability measured using the Oswestry Disability Index
Secondary Outcomes
- 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))