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

NCT07248813 | Recruiting

• 1 other identifier: R-2025-1401-018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

Keywords

TELEMEDICINE; Physical Therapy; Primary Care; Oswestry Disability Index; Rehabilitation Program; Telerehabilitation; Pragmatic Clinical Trial; Pain Management; Adherence

Outcome Measures

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).

  Baseline and 6 weeks after randomization

Secondary Outcomes (3)

• Pain Intensity

  Baseline and 6 weeks after randomization

• Participant Satisfaction

  At the end of the 6-week intervention

• Time to Functional Recovery

  Up to 6 weeks after baseline

Other Outcomes (1)

• Adherence to the Telerehabilitation Program

  Throughout the 6-week intervention period

Study Arms (2)

Telerehabilitation plus Conventional Care

EXPERIMENTAL

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; Other: Conventional care

Conventional Care Only

ACTIVE COMPARATOR

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

Interventions

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.

Telerehabilitation plus Conventional Care

Conventional care OTHER

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

Conventional Care Only; Telerehabilitation plus Conventional Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Family Medicine Unit No. 69, Mexican Institute of Social Security (IMSS)

México, Texcoco, 56100, Mexico

RECRUITING

Related Publications (4)

• Simsek A, Ulger O. Effectiveness of telerehabilitation exercises in low back pain: a systematic review. Ir J Med Sci. 2025 Oct;194(5):1903-1913. doi: 10.1007/s11845-025-04051-x. Epub 2025 Aug 13.

  PMID: 40802146 BACKGROUND

• Villatoro-Luque FJ, Rodriguez-Almagro D, Aibar-Almazan A, Fernandez-Carnero S, Pecos-Martin D, Ibanez-Vera AJ, Castro-Martin E, Achalandabaso-Ochoa A. Telerehabilitation for the treatment in chronic low back pain: A randomized controlled trial. J Telemed Telecare. 2025 Jun;31(5):637-646. doi: 10.1177/1357633X231195091. Epub 2023 Aug 30.

  PMID: 37649362 BACKGROUND

• Lara-Palomo IC, Gil-Martinez E, Ramirez-Garcia JD, Capel-Alcaraz AM, Garcia-Lopez H, Castro-Sanchez AM, Antequera-Soler E. Efficacy of e-Health Interventions in Patients with Chronic Low-Back Pain: A Systematic Review with Meta-Analysis. Telemed J E Health. 2022 Dec;28(12):1734-1752. doi: 10.1089/tmj.2021.0599. Epub 2022 May 9.

  PMID: 35532971 BACKGROUND

• Sivertsson J, Sernert N, Ahlund K. Exercise-based telerehabilitation in chronic low back pain - a scoping review. BMC Musculoskelet Disord. 2024 Nov 23;25(1):948. doi: 10.1186/s12891-024-07952-7.

  PMID: 39580408 BACKGROUND

Related Links

• World Health Organization - Digital Health and Telemedicine. Offers information on digital health strategies, including telemedicine and remote rehabilitation, endorsed by the World Health Organization.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arlette R. Ordoñez Flores, MD, MSc

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

ARLETTE R. ORDOÑEZ FLORES, MD, MSc

CONTACT

+52 55 59950338; dra.ordonez.rehab@gmail.com

David R Mejía, MD, PhD

CONTACT

+5255 44803648; rojanodavid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts are blinded to group allocation. Participants and care providers are not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group receives conventional care plus a six-week telerehabilitation program, while the control group receives conventional care only. Both groups are followed in parallel without crossover.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)