How exercise affects the immune system and brain in chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Montreal General Hospital
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Carlos Gevers Montoro, PhD
• Email: backpain@muhc.mcgill.ca
• Phone: +1-8199790448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.