Telerehabilitation Program to Improve Function in People With Chronic Low Back Pain Compared With Conventional Care (TELEREHAB-LC)

November 18, 2025 updated by: Coordinación de Investigación en Salud, Mexico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low back pain is the leading cause of musculoskeletal disability worldwide and represents one of the main reasons for medical consultation and work incapacity within the Mexican Institute of Social Security (IMSS). In Mexico, approximately 30 % of adults experience low back pain, and this condition is among the top ten causes of temporary work disability in the IMSS. Delays in referral to rehabilitation services often extend recovery time, increase institutional costs, and limit patients' functional reintegration.

Telerehabilitation has emerged as a promising alternative to improve accessibility, continuity of care, and adherence in musculoskeletal conditions. It allows the delivery of structured therapeutic exercise programs and education modules through digital platforms, reducing logistical barriers and waiting times. However, evidence on its clinical effectiveness in public healthcare systems, particularly in pragmatic real-world settings such as IMSS primary care units, remains scarce.

This pragmatic randomized controlled clinical trial aims to evaluate the effectiveness and feasibility of an additional telerehabilitation program combined with conventional care, compared with conventional care alone, in improving functional outcomes in adults with chronic non-specific low back pain. The study is conducted at Family Medicine Unit No. 69 (UMF 69) in Texcoco, State of Mexico, which provides first-level care for musculoskeletal disorders.

Participants aged 18-60 years with clinically diagnosed chronic low back pain (duration ≥ 12 weeks) are recruited consecutively from IMSS outpatient consultations. After obtaining informed consent, eligible participants are randomly assigned in a 1:1 ratio to either the intervention group (telerehabilitation + conventional care) or the control group (conventional care only), using a computer-generated randomization list with concealed allocation. Outcome assessors and data analysts remain blinded to group assignment.

The telerehabilitation program consists of a six-week structured protocol delivered through the Moodle platform and supported by WhatsApp communication. It includes five progressive modules that integrate:

Education on disease understanding and self-management.

Spine hygiene and ergonomic recommendations.

Physical therapy exercises based on Williams and McKenzie methods.

Core strengthening and stretching routines.

Relaxation and breathing techniques adapted from Jacobson's progressive relaxation.

Weekly asynchronous educational videos are complemented by one live (synchronous) virtual session per week, promoting interaction and motivation. Participants record their daily exercises and pain levels in printed or digital logs, which are reviewed weekly. Adherence is monitored by login frequency, participation in virtual sessions, and completion of exercise diaries.

The control group receives conventional medical management from family physicians, which may include pharmacologic therapy (analgesics, NSAIDs), ergonomic advice, and distribution of the institutional educational brochure on back hygiene and exercise (Williams series). This reflects the routine standard of care in IMSS primary care settings and intentionally preserves clinical variability to enhance external validity.

The primary outcome is functional improvement measured by the Oswestry Disability Index (ODI), comparing baseline and six-week scores between groups. The secondary outcomes include pain intensity (Visual Analogue Scale, VAS), time to functional recovery, adherence to the intervention, and participant satisfaction. The study hypothesizes that the telerehabilitation program will achieve a ≥ 10-point greater reduction in ODI scores (the minimal clinically important difference) compared with conventional care.

A total of 200 participants (100 per group) will be included, accounting for an expected 40 % attrition rate and ensuring sufficient power (80 %) to detect the predefined difference. Data will be analyzed under the intention-to-treat principle using ANCOVA adjusted for confounders (age, body-mass index, comorbidities, and physical activity level). Complementary logistic regression will assess the proportion of participants achieving clinically meaningful improvement.

This pragmatic design reflects real-world clinical practice and aims to generate evidence directly applicable to IMSS settings. The study's feasibility is supported by existing infrastructure, including access to the IMSS Moodle platform, telecommunication tools, and trained personnel in rehabilitation medicine.

The trial is classified as greater-than-minimal risk under Mexican health regulations because it involves an experimental therapeutic modality; however, it is considered low physical risk since all exercises correspond to standard rehabilitation practice. Ethical approval was granted by the Local Research and Ethics Committee No. 1401 (IMSS), and all participants provide written informed consent. Participant confidentiality is protected according to Mexican data protection law and institutional guidelines.

The study adheres to the Declaration of Helsinki, the Belmont Report, and the General Health Law on Research for Human Subjects (Mexico). The trial's oversight and safety monitoring are performed by the principal investigator and the local ethics board; no independent Data Monitoring Committee is established, given the minimal risk of the intervention.

If proven effective, this program could provide an accessible, low-cost, and scalable rehabilitation strategy within primary care, reducing disability, improving patient satisfaction, and optimizing healthcare resources. The findings will support institutional decision-making for the gradual implementation of telerehabilitation across IMSS facilities and contribute to national strategies for strengthening rehabilitation services, as recommended by the World Health Organization.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Texcoco
      • México, Texcoco, Mexico, 56100
        • Recruiting
        • Family Medicine Unit No. 69, Mexican Institute of Social Security (IMSS)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation plus Conventional Care
Participants in this group receive a six-week telerehabilitation program in addition to conventional medical care for chronic low back pain. The telerehabilitation program is delivered through the Moodle platform and includes educational videos, stretching and strengthening exercises based on Williams and McKenzie methods, core stabilization routines, relaxation techniques, and weekly virtual sessions. Conventional care includes physician consultations, analgesic treatment as needed, and ergonomic advice.
Behavioral: Telerehabilitation Program
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.
Other: Conventional care
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
Active Comparator: Conventional Care Only
Participants in this group receive standard medical care for chronic low back pain provided at IMSS primary care clinics. This includes physician consultations, pharmacologic management (analgesics, NSAIDs), ergonomic recommendations, and the institutional educational brochure on back hygiene and exercises. No telerehabilitation components are provided.
Other: Conventional care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional improvement measured by the Oswestry Disability Index (ODI)
Time Frame: Baseline and 6 weeks after randomization
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).
Baseline and 6 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline and 6 weeks after randomization
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).
Baseline and 6 weeks after randomization
Participant Satisfaction
Time Frame: At the end of the 6-week intervention
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.
At the end of the 6-week intervention
Time to Functional Recovery
Time Frame: Up to 6 weeks after baseline
Time (in days) from enrollment to the first report of ≥10-point reduction in ODI score, representing the minimal clinically important difference (MCID).
Up to 6 weeks after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the Telerehabilitation Program
Time Frame: Throughout the 6-week intervention period
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.
Throughout the 6-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Instituto Mexicano del Seguro Social
Universidad Nacional Autonoma de Mexico

Investigators

  • Principal Investigator: Arlette R. Ordoñez Flores, MD, MSc, Instituto Mexicano del Seguro Social
  • Study Chair: David R. Mejía, MD, PhD, Instituto Mexicano del Seguro Social
  • Study Chair: José de Jesús R. Sánchez, MD, PhD, Hospital General de México Eduardo Liceaga
  • Study Chair: Rodolfo P. Almazán, PhD, National Polytechnic Institute, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2025

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2025-1401-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the dataset contains confidential health information owned by the Mexican Institute of Social Security (IMSS). Data sharing is restricted by institutional and national regulations on personal data protection. Only aggregated and anonymized results will be available upon reasonable request and after institutional approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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