Telerehabilitation-based Exercises vs Standard Home-based Exercise in Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK, Standard home-based exercise.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Other Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through the software a digital physiotherapy and telerehabilitation. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of the TRAK software (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, of - Other Standard home-based exercise
8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through a dossier and an exercise diary. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. 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.. As an addition to the home sessions, two face-to-face s
Primary outcome measures
- Disability [Time frame: 8 weeks measurement (post intervention)]
Secondary outcome measures (12)
- Disability [Time frame: Baseline; 32 weeks measurement (24 weeks post intervention)]
- Range of movement (Schober score) [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Range of movement (Finger floor distance test) [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Extensor low back muscle strength [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Muscle thickness (low back extensor muscles) [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Muscle thickness (transversus abdominis) [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Low Back Pain [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Medication intake [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Kinesiphobia [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Depression [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Fear Avoidance Beliefs [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
- Fear Avoidance Components [Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- University of Valencia — Valencia
Identifiers
NCT: NCT06446596 · Telerehab_Low_back_pain