How exercise affects the immune system and brain in chronic low back pain
Neuroimmune Responses to Physical Exercise Training in Chronic Primary Low Back Pain
This trial will test whether a 12-week online exercise program changes immune activity, brain function, and pain for adults with chronic low back pain compared with a waitlist group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07497425 on ClinicalTrials.gov |
What this trial studies
This randomized mechanistic trial will enroll 144 adults with chronic low back pain who will be assigned to a 12-week online physical exercise program or a waitlist control, with 72 age- and sex-matched healthy controls for baseline comparison. Participants will complete questionnaires, movement-evoked pain and sensory testing, heart rate variability measures, blood draws for whole-blood transcriptomics, and multimodal MRI to characterize neural function. The study will also measure acute immune and autonomic responses to initial exercise sessions to see how short-term changes relate to longer-term adaptations. Data will be compared between CLBP participants and healthy controls and between the exercise and waitlist groups to link immune, neural, and clinical changes.
Who should consider this trial
Good fit: Adults with chronic primary low back pain lasting at least 3 months (or recurrent for at least half the days in the past 6 months) who report average pain of at least 4/10 and can attend hospital visits and follow an online exercise program are ideal candidates.
Not a fit: People with red-flag conditions or serious underlying pathology, those who do not meet the CLBP diagnostic criteria or pain threshold, or those unable to undergo MRI, blood draws, or participate in online exercise are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could reveal how exercise reduces pain and identify physiological markers to guide more targeted exercise treatments for chronic low back pain.
How similar studies have performed: Exercise is already known to help chronic low back pain and to influence inflammation and brain function, but combining immune gene-expression profiling with multimodal MRI in a randomized mechanistic trial is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Montreal, Quebec
- Montreal General Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Carlos Gevers Montoro, PhD
- Email: carlos.geversmontoro@mcgill.ca
- Phone: +1-8199790448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.