Neuroimmune Responses to Exercise in Chronic Back Pain
ConditionChronic Low Back Pain (CLBP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMcGill University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Exercise
BehavioralPatients 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.
Treatment groups
216 Participants
are divided into 3 treatment groupsGroup A: Active interventionExperimental treatment 1 intervention
Group B: WaitlistNo intervention 0 interventions
Group C: Healthy controlsOther 1 intervention
Trial outcomes
Primary outcomes
1
Chronic Low Back Pain Intensity
Self-reported low back pain intensity averaged over the past 7 days, measured using an 11-point Numerical Rating Scale (NRS; 0-10), where 0 = "no pain" and 10 = "worst imaginable pain." Item from the NIH minimum dataset on research standards for chronic low back pain. Data collected in REDCap.
Time frame
Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, assessed daily through electronic pain diaries.Secondary outcomes
1
Peripheral Blood Gene Expression (RNA Sequencing)
Gene expression levels assessed in peripheral blood using RNA sequencing. Transcriptomic analyses evaluated differential gene expression and pathway analyses.
Time frame
Blood samples collected at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, samples also collected 14, 48 hours and 2 weeks after the first exercise session or at equivalent times for waitlist participants2
Nucleus Accumbens-Medial Prefrontal Cortex Functional Connectivity
Functional connectivity assessed using resting-state functional magnetic resonance imaging (rsfMRI). Seed-to-voxel analyses performed using anatomically defined bilateral nucleus accumbens and medial prefrontal cortex regions.
Time frame
MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)3
Fractional Anisotropy of NAc-mPFC White Matter Tract
Fractional Anisotropy (FA) measured using diffusion-weighted imaging (DWI) probabilistic tractography along the white matter connecting the nucleus accumbens and medial prefrontal cortex.
Time frame
MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)4
Whole-Brain Intrinsic Connectivity
Intrinsic connectivity analysis (voxel-wise network centrality; root mean square of all functional connections) performed using resting-state functional magnetic resonance imaging (rsfMRI) to quantify whole-brain functional connectivity.
Time frame
MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)Other outcomes
1
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) assesses catastrophic thinking related to pain, including rumination, magnification, and helplessness. The scale contains 13 items rated on a 5-point scale (0-4). Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing. Data collected in REDCap.
Time frame
Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)2
Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia (TSK) assesses fear of movement and injury related to pain. The questionnaire contains 17 items rated on a 4-point Likert scale. Total scores range from 17 to 68, with higher scores indicating greater fear of movement. Data collected in REDCap.
Time frame
Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)3
Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire (PSEQ) assesses confidence in performing activities despite pain. The questionnaire contains 10 items rated on a 7-point scale (0-6). Total scores range from 0 to 60, with higher scores indicating greater pain self-efficacy. Data collected in REDCap.
Time frame
Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)4
Beck Depression Inventory
The Beck Depression Inventory-II (BDI-II) assesses severity of depressive symptoms. The instrument contains 21 items rated on a 4-point scale (0-3). Total scores range from 0 to 63, with higher scores indicating greater depressive symptom severity. Data collected in REDCap.
Time frame
Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)Sponsors and contacts
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Source ClinicalTrials.gov