Recruiting

Exercise

Sponsor:

McGill University

Code:

NCT07497425

Conditions

Chronic Low Back Pain (CLBP)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Physical Exercise

Study Details

Brief summary:

The goal of this mechanistic clinical trial is to learn how physical exercise affects the body and brain in people with chronic low back pain. The study will examine whether a 12-week online exercise program changes these measures compared with a waitlist group. Researchers will also study immune activity and brain function in people with chronic low back pain and compare them with healthy participants. Participants will complete questionnaires, provide blood samples, and undergo brain imaging scans.

Conditions

Chronic Low Back Pain (CLBP)

Study ID

NCT07497425

Start date

Jun 1, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria-CLBP patients:

  • Have a diagnosis of chronic primary LBP, according to the criteria established by NIH Task Force on Research Standards for CLBP (Deyo et al., 2015). This will be determined by 1) the response to the National Institutes of Health minimum dataset for CLBP (NIH-md), including that LBP has been persistent for at least 3 months or recurrent for at least half of the days in the past 6 months, and 2) the results of a complete case history and physical examination (including functional tasks, quantitative sensory testing, and, if needed, neuro-orthopedic, palpation and range of motion assessments);
  • Report a CLBP intensity of at least 4 in a 0-10 numerical rating scale (0 = no pain, 10 = maximum possible pain).

Inclusion Criteria-Healthy controls:

\- Be over 18 years and under 75 years of age;

Exclusion Criteria-CLBP patients:

  • Present any red flags indicative of serious pathology comorbid or as the cause of CLBP (Finucane et al., 2020);
  • Have a CLBP phenotype characterized by predominant nociceptive (as in fracture, infection, malignancy, inflammatory or rheumatic spondyloarthropathy, cauda equina syndrome, confirmed by MRI when suspected) or neuropathic pain mechanisms, the latter assessed through score in the DN4 questionnaire (Nijs, et al., 2024);
  • Present chronic or acute pain of higher intensity or perceived disability in any other body site than the low back;
  • Medical history of diabetes, neurological or psychiatric disorder;
  • Presence of significant cardiorespiratory problems or any other potential contraindications to physical exercise as assessed through the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
  • Following a regular structured PE training program (>60 min/week) at study's onset, and;
  • Presence of any contraindications to MRI examination (including any metallic implants or devices, being pregnant, and claustrophobia).

Exclusion criteria-Healthy controls:

  • Have symptoms or a diagnosis of any acute or chronic pain conditions;
  • Medical history of diabetes, neurological or psychiatric disorder;
  • Presence of significant cardiorespiratory problems or any other potential contraindications to physical exercise as assessed through the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
  • Following a regular structured PE training program (>60 min/week) at study's onset, and;
  • Presence of any contraindications to MRI examination (including any metallic implants or devices, being pregnant, and claustrophobia).

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Active intervention

Physical Exercise Training

no intervention: Waitlist

Participants assigned to the waitlist group will not receive the physical exercise program during the 12-week intervention period but will continue their usual care. After completion of the study assessments, they will be offered access to the exercise program.

other: Healthy controls

Sex- and age-matched healthy volunteers will only participate in the first 2 weeks of PE intervention

Interventions

Physical Exercise

Patients in the PE training group will perform a 12-week online program comprising three 60-minute weekly training sessions. The training program is delivered by certified kinesiologists through a secured online platform.

Healthy controls will participate only in the first 2 weeks of PE training.

Primary outcome measure

  • Chronic Low Back Pain Intensity [ Time Frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, assessed daily through electronic pain diaries. ]

Central Contacts and Locations

Central contacts

Carlos Gevers Montoro, PhD

+1-8199790448backpain@muhc.mcgill.ca

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3H 1V6

Contacts

Carlos Gevers Montoro, PhD

+1-8199790448backpain@muhc.mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • mechanisms
  • immune system
  • inflammation
  • brain
  • chronic pain
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by McGill University on 2026-08-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.