Telerehabilitation Program to Improve Function in People With Chronic Low Back Pain Compared With Conventional Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCoordinación de Investigación en Salud, Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telerehabilitation Program

    Behavioral

    A six-week telerehabilitation program provided in addition to conventional medical care for patients with chronic low back pain. The program is delivered through the Moodle platform and supported by WhatsApp communication. It includes five progressive modules with educational videos, stretching and strengthening exercises based on Williams and McKenzie methods, core stabilization and flexibility routines, and relaxation techniques adapted from Jacobson's progressive relaxation. Participants complete home-based exercises and one weekly virtual session, record their activities in logs, and receive feedback from the rehabilitation team.

  • Conventional care

    Other intervention

    Standard medical care provided at IMSS primary care clinics for patients with chronic low back pain. It includes physician consultations, pharmacologic management as needed (analgesics, NSAIDs), ergonomic and posture advice, and the institutional educational brochure on back hygiene and exercises. No telerehabilitation components are included

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Telerehabilitation plus Conventional CareExperimental treatment 2 interventions
Group B: Conventional Care OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional improvement measured by the Oswestry Disability Index (ODI)

Change in functional disability score assessed using the validated Spanish version of the Oswestry Disability Index (ODI). The scale measures the degree of disability related to low back pain across 10 domains (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment). Scores range from 0 (no disability) to 100 (maximum disability).

Time frame
Baseline and 6 weeks after randomization

Secondary outcomes

1

Pain Intensity

Change in pain intensity measured using the Visual Analogue Scale (VAS). Participants rate their average pain over the previous week on a 10 cm line ranging from 0 (no pain) to 10 (worst imaginable pain).

Time frame
Baseline and 6 weeks after randomization
2

Participant Satisfaction

Satisfaction with the intervention measured using a Likert-type questionnaire (1-5 scale) evaluating accessibility, clarity of information, usefulness of exercises, and overall satisfaction with care.

Time frame
At the end of the 6-week intervention
3

Time to Functional Recovery

Time (in days) from enrollment to the first report of ≥10-point reduction in ODI score, representing the minimal clinically important difference (MCID).

Time frame
Up to 6 weeks after baseline

Other outcomes

1

Adherence to the Telerehabilitation Program

Percentage of participants who complete at least 80% of the telerehabilitation sessions and daily exercise logs. Adherence is tracked through Moodle platform activity, attendance at virtual sessions, and completion of exercise diaries.

Time frame
Throughout the 6-week intervention period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coordinación de Investigación en Salud, Mexico

Lead sponsor

Instituto Mexicano del Seguro Social

Collaborator

Universidad Nacional Autonoma de Mexico

Collaborator