Chronic Low Back Pain (Non-specific, Uncomplicated)TELEREHAB-LCNCT07248813
Telerehabilitation Program to Improve Function in People With Chronic Low Back Pain Compared With Conventional Care
A study testing Telerehabilitation Program and Conventional care in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- Telerehabilitation Program and Conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 3 Oct 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Family Medicine Unit No. 69, Mexican Institute of Social Security (IMSS)
México, Texcoco, 56100
Arlette R. Ordoñez Flores, MD, MSc, +525559950338, dra.ordonez.rehab@gmail.com
David P. Ordoñez Flores, MD, MSc, +5255 44803648, ettelra80@hotmail.com
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- Telerehabilitation Program, Conventional care
- Keywords
- TELEMEDICINE, Physical Therapy, Primary Care, Oswestry Disability Index, Rehabilitation Program, Telerehabilitation, Pragmatic Clinical Trial, Pain Management, Adherence
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation ProgramBehavioural
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 careOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 6 weeks after randomization
Secondary outcomes (3)
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).
Measured: Baseline and 6 weeks after randomization
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.
Measured: At the end of the 6-week intervention
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).
Measured: Up to 6 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start3 Oct 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (Non-specific, Uncomplicated)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social, Universidad Nacional Autonoma de Mexico
- Responsible party
- Sponsor
- Investigators
- Arlette R. Ordoñez Flores, MD, MSc, Principal investigator, Instituto Mexicano del Seguro SocialDavid R. Mejía, MD, PhD, Study chair, Instituto Mexicano del Seguro SocialJosé de Jesús R. Sánchez, MD, PhD, Study chair, Hospital General de México Eduardo LiceagaRodolfo P. Almazán, PhD, Study chair, National Polytechnic Institute, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248813
- Sponsor's protocol ID
- R-2025-1401-018
- Acronym
- TELEREHAB-LC
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40802146Villatoro-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.
PubMed 37649362Lara-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.
PubMed 35532971Sivertsson 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.
PubMed 39580408
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07248813
- Acronym / sponsor ID
- TELEREHAB-LC / R-2025-1401-018
- Keywords
- TELEMEDICINE, Physical Therapy, Primary Care, Oswestry Disability Index, Rehabilitation Program, Telerehabilitation, Pragmatic Clinical Trial, Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social, Universidad Nacional Autonoma de Mexico
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation plus Conventional Care | Experimental | Behavioral: Telerehabilitation Program, Other: Conventional careParticipants 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. |
| Conventional Care Only | Active comparator | Other: Conventional careParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation ProgramA 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. | Behavioural | Telerehabilitation plus Conventional Care |
| Conventional careStandard 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 | Other | Conventional Care Only, Telerehabilitation plus Conventional Care |
Primary outcome
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).
3 secondary outcomes
Pain Intensity
Time frame: Baseline and 6 weeks after randomization
Participant Satisfaction
Time frame: At the end of the 6-week intervention
Time to Functional Recovery
Time frame: Up to 6 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 40802146Simsek 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.
- Background: PubMed 37649362Villatoro-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.
- Background: PubMed 35532971Lara-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.
- Background: PubMed 39580408Sivertsson 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.
- World Health Organization - Digital Health and Telemedicine. Offers information on digital health strategies, including telemedicine and remote rehabilitation, endorsed by the World Health Organization.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arlette R. Ordoñez Flores, MD, MSc principal investigator
Instituto Mexicano del Seguro Social
David R. Mejía, MD, PhD study chair
Instituto Mexicano del Seguro Social
José de Jesús R. Sánchez, MD, PhD study chair
Hospital General de México Eduardo Liceaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Program and Conventional care in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ARLETTE R. ORDOÑEZ FLORES, MD, MSc (+52 55 59950338, dra.ordonez.rehab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional improvement measured by the Oswestry Disability Index (ODI) (time frame: Baseline and 6 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248813, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.