Neuroimmune Responses to Exercise in Chronic Back Pain
- NCT ID
- NCT07497425
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- McGill University
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 216 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- Yes
ClinicalTrials.gov lists the following eligibility 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).
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Canada
- Quebec, Canada: 1
Sample of listed locations
- Montreal General Hospital — Montreal, Quebec, H3H 1V6, Canada — Site recruitment status not specified in the registry data
Study details
- Start date
- June 1, 2025
- Primary completion date
- December 31, 2028
- First posted
- March 27, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07497425
- Registry last updated
- August 19, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07497425 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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