Telerehabilitation Program to Improve Function in People With Chronic Low Back Pain Compared With… (NCT07248813) | Clinical Trial Compass
RecruitingNot Applicable
Telerehabilitation Program to Improve Function in People With Chronic Low Back Pain Compared With Conventional Care
Mexico200 participantsStarted 2025-10-03
Plain-language summary
The goal of this clinical trial is to evaluate whether an additional telerehabilitation program, combined with conventional care, can improve functional recovery in adults with chronic low back pain treated in primary care clinics of the Mexican Institute of Social Security (IMSS).
The main questions it aims to answer are:
* Does the telerehabilitation program lead to greater functional improvement, measured by the Oswestry Disability Index (ODI), compared with conventional care alone?
* Does the program reduce pain intensity and improve adherence and satisfaction among participants?
Researchers will compare patients receiving conventional care plus telerehabilitation with those receiving conventional care only to determine whether the digital intervention provides additional clinical benefits.
Participants will:
* Continue their usual medical care for chronic low back pain at IMSS clinics.
* Follow a 6-week telerehabilitation program delivered through an online platform, including educational videos, stretching and strengthening exercises, and weekly virtual check-ins.
* Complete baseline and post-intervention assessments of pain, disability, and satisfaction.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults between 18 and 60 years of age.
* Clinical diagnosis of chronic non-specific low back pain (duration ≥ 12 weeks).
* Pain intensity ≥ 3 on the Visual Analogue Scale (VAS) at baseline.
* Enrolled as beneficiaries of the Mexican Institute of Social Security (IMSS) and receiving care at a primary care clinic.
* Access to a smartphone or computer with internet connection.
* Ability to read and understand written instructions in Spanish.
* Willingness to participate and provide written informed consent.
Exclusion Criteria:
* Specific causes of low back pain (e.g., fractures, tumors, infections, inflammatory or rheumatic diseases).
* Neurological deficits suggestive of radiculopathy or myelopathy.
* Pregnancy.
* Severe psychiatric or cognitive disorders that limit participation.
* Recent spinal surgery (within the last 6 months).
* Participation in another rehabilitation or exercise program for low back pain within the previous 3 months.
* Any medical condition that contraindicates physical exercise, as determined by the treating physician.
The upper age limit of 60 years was established to minimize confounding factors related to advanced degenerative joint disease. Individuals older than 60 frequently present radiographic or clinical signs of grade III or higher lumbar osteoarthritis, which may produce chronic pain and functional limitation independent of the intervention. Including these participants could obscure the true effect of the telerehabil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional improvement measured by the Oswestry Disability Index (ODI)
Timeframe: Baseline and 6 weeks after randomization
Trial details
NCT IDNCT07248813
SponsorCoordinación de Investigación en Salud, Mexico