NCT07248813

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Low Back Pain (Non-specific, Uncomplicated)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-03
• Primary completion: 2026-11-15
• Completion: 2026-12-20
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: Mexico