Telerehabilitation program to improve function in adults with chronic low back pain
Effectiveness of an Additional Telerehabilitation Program Combined With Conventional Care on Functional Improvement in Patients With Chronic Low Back Pain at the Primary Care Level in the Mexican Institute of Social Security (IMSS): A Pragmatic Randomized Controlled Trial
This trial will test whether adding a 6-week online telerehabilitation program to usual care helps adults with chronic non-specific low back pain improve function, reduce pain, and increase treatment adherence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (México, Texcoco) |
| Trial ID | NCT07248813 on ClinicalTrials.gov |
What this trial studies
This pragmatic randomized controlled trial enrolls IMSS beneficiaries aged 18–60 with chronic non-specific low back pain treated at Family Medicine Unit No. 69 in Texcoco. Participants are randomized to receive usual primary care alone or usual care plus a 6-week telerehabilitation program delivered through an online platform with structured exercises and education. The primary outcome is change in function measured by the Oswestry Disability Index, with secondary outcomes including pain intensity, adherence, and patient satisfaction. The design tests the feasibility and added clinical benefit of a digital rehabilitation program in a real-world public healthcare setting.
Who should consider this trial
Good fit: Ideal candidates are IMSS beneficiaries aged 18–60 with chronic non-specific low back pain lasting at least 12 weeks, baseline pain ≥3/10, and access to a smartphone or computer with internet.
Not a fit: Patients with specific spinal pathology (fracture, tumor, infection, inflammatory disease), neurological deficits suggestive of radiculopathy or myelopathy, recent spinal surgery, pregnancy, severe cognitive or psychiatric impairment, or without internet access are unlikely to be eligible or to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve functional recovery and reduce pain while increasing access to and adherence with rehabilitation in a public health system.
How similar studies have performed: Previous randomized trials and systematic reviews of telerehabilitation and remotely delivered exercise for chronic low back pain have shown outcomes comparable to or modestly better than usual care, but evidence in public primary care settings like IMSS remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 telerehabilitation program on functional improvement and pain reduction in patients with non-specific chronic low back pain.
Where this trial is running
México, Texcoco
- Family Medicine Unit No. 69, Mexican Institute of Social Security (IMSS) — México, Texcoco, Mexico (Recruiting)
Study contacts
- Principal investigator: Arlette R. Ordoñez Flores, MD, MSc — Instituto Mexicano del Seguro Social
- Study coordinator: ARLETTE R. ORDOÑEZ FLORES, MD, MSc
- Email: dra.ordonez.rehab@gmail.com
- Phone: +52 55 59950338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.