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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