An interventional study of Physical Exercise in Chronic Low Back Pain (CLBP), sponsored by McGill University. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by McGill University · Not applicable, Interventional, and Basic science
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.
Chronic low back pain (CLBP) is the leading cause of disability worldwide, yet its underlying mechanisms remain poorly understood, limiting treatment effectiveness. Growing evidence suggests that CLBP is not solely driven by peripheral tissue pathology but involves maladaptive interactions between the immune system and the brain, particularly within reward- and emotion-related brain circuits. Physical exercise (PE) is universally recommended for CLBP and is known to influence both inflammatory processes and brain function, but the neuroimmune mechanisms through which PE alleviates pain are largely unknown. This study aims to address this critical gap by characterizing immune, neural, and autonomic alterations in CLBP and their modulation through structured PE training.
In this mechanistic randomized controlled trial, 144 individuals with CLBP will be randomized to a 12-week online PE program or a waitlist control, and 72 age- and sex-matched healthy controls will serve as comparators for baseline values and response to acute PE. Participants will undergo comprehensive assessments including questionnaires, movement-evoked pain testing, quantitative sensory testing, heart rate variability, blood sampling for immune gene expression (through whole blood transcriptomics), and multimodal MRI. Acute immune and autonomic responses to initial exercise sessions will also be examined to test whether short-term pro-inflammatory responses initiate longer-term adaptive and analgesic processes. By integrating immune, brain, and behavioral data, this study seeks to elucidate how neuroimmune interactions contribute to CLBP persistence and recovery, providing mechanistic insights to optimize exercise-based treatments.
In June 2025, the investigators initiated an initial pilot phase within the present trial to determine the feasibility of our recruitment strategies (recruitment of patient cohorts of 5-8 patients who will receive the PE intervention or be waitlisted according to block randomization) and compliance with the exercise program/waitlist protocol, and all intermediary data collection points. Feasibility was confirmed in February 2026, and recruitment of subsequent cohorts is planned to continue in March 2026. All future data collection will use the same core procedures and outcomes as the pilot phase, therefore, data collected during the pilot phase will be retained and may be included in the final analyses where appropriate.
At the time of this registration, preliminary analyses have only been conducted for the primary clinical outcome (pain intensity) as part of our assessment of feasibility. No inferential analyses have been conducted. Analyses of biological and neuroimaging measures, including transcriptomic and brain imaging data, are contingent on funding acquisition.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's planned enrollment of 216 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
Compared within Inflammation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria-CLBP patients:
Inclusion Criteria-Healthy controls:
- Be over 18 years and under 75 years of age;
Exclusion Criteria-CLBP patients:
Exclusion criteria-Healthy controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physical Exercise Training
Behavioral: Physical Exercise
Participants assigned to the waitlist group will not receive the physical exercise program during the 12-week intervention period but will continue their usual care. After completion of the study assessments, they will be offered access to the exercise program.
Sex- and age-matched healthy volunteers will only participate in the first 2 weeks of PE intervention
Behavioral: Physical Exercise
Patients 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.
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.
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 participants
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)
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)
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)
Tonic Pain Signature (ToPS)
Expression of the Tonic Pain Signature (ToPS), a multivariate brain biomarker derived from whole-brain functional connectivity patterns predictive of sustained pain intensity. The ToPS score will be computed from resting-state fMRI data using validated model weights and applied to participant-level connectivity matrices.
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Nociplastic Functional Signature (NFS)
Expression of the Nociplastic Functional Signature (NFS), a brain-based connectivity biomarker trained to classify nociplastic pain conditions. NFS scores will be calculated from resting-state fMRI connectivity patterns to quantify the presence of nociplastic pain-related network dysconnectivity.
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Hippocampal volume
Structural volume of the bilateral hippocampus measured from T1-weighted anatomical MRI using automated segmentation. Hippocampal volume alterations have been reported in chronic pain populations and may reflect changes associated with pain chronification.
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Superior Longitudinal Fasciculus (SLF) White Matter Integrity
Microstructural integrity of the Superior Longitudinal Fasciculus (SLF) assessed using DWI metrics (fractional anisotropy, mean diffusivity). The SLF is a major fronto-parietal white-matter tract implicated in cognitive control, attention, and pain modulation networks. Loss of integrity in this tract may be associated with chronic pain severity.
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Heart rate variability: RMSSD
Heart rate variability will be assessed using the root mean square of successive differences (RMSSD), a time-domain measure reflecting parasympathetic (vagal) cardiac modulation. 5 minutes of resting electrocardiogram (ECG) signals will be recorded using BIOPAC systems and processed using Kubios HRV software.
Time frame: ECG will be collected at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, ECG also conducted 14, 48 hours and 2 weeks after the first exercise session or at equivalent times for waitlist participants
NIH minimum dataset pain impact stratification subscale
Pain-related impact (pain impact stratification, 9 items 0-50), higher scores indicate greater pain impact on function. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
NIH minimum dataset emotional depression and distress subscale
Pain-related emotional depression and distress (EDD, 4 items 0-16), higher scores indicate greater pain impact on this dimension. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
NIH minimum dataset sleep disturbance subscale
Pain-related sleep disturbance (SlD, 2 items 0-8), higher scores indicate greater pain impact on this dimension. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Oswestry Low Back Pain Disability Index (ODI)
Pain-related disability measured using the Oswestry Low Back Pain Disability Questionnaire (10 items). Each item is scored from 0-5, yielding a total score ranging from 0-50, with higher scores indicating greater disability. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Fatigue severity scale
The Fatigue Severity Scale (FSS) assesses the impact of fatigue on daily functioning. The questionnaire contains 9 items, each rated on a 7-point Likert scale (1-7). Scores are averaged across items, with higher scores indicating greater fatigue severity and functional impairment. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and sleep disturbances over the past month. The instrument contains 19 self-rated items, generating 7 component scores summed into a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Snaith-Hamilton pleasure scale
The Snaith-Hamilton Pleasure Scale (SHAPS) assesses anhedonia (reduced ability to experience pleasure). The scale contains 14 items evaluating pleasure responses to everyday experiences. Total scores range from 0 to 14, with higher scores indicating greater anhedonia. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Multiple abilities self-assessed questionnaire
The Multiple Ability Self-Report Questionnaire (MASQ) assesses self-perceived cognitive functioning in everyday life, including language, memory, attention, and visuospatial abilities. The questionnaire contains 38 items rated on a 5-point Likert scale. Total scores range from 38 to 190, with higher scores indicating greater perceived cognitive difficulties, as well as five subscales for specific cognitive dimensions: Language, Verbal Memory, Visual Memory, Visuo-perceptual Ability, and Attention/Concentration. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Movement-evoked pain
Movement-evoked pain (MeP) will be assessed as the difference between pain at rest and the peak pain intensity reported during or immediately after four movement tasks: balance, sit-to-stand, a tailored provocative movement, and a tailored lifting task. Pain intensity will be rated using a 0-10 Numerical Rating Scale (NRS) before, during and after each task. MeP is calculated with the formula (Peak Pain During/After Task - Pain at Rest), for a score ranging from -10 to +10. An aggregate MeP score will also be calculated as the sum of the score obtained from each task (ranging from -40 to +40).
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
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)
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)
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)
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)
State anxiety inventory
The State Anxiety Inventory (STAI-State) assesses current levels of anxiety. The questionnaire contains 20 items rated on a 4-point scale. Total scores range from 20 to 80, with higher scores indicating greater state anxiety. Data collected in REDCap.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Pressure pain thresholds
Pressure pain thresholds (PPTs) will be measured in kgs using a Wagner FDx algometer. The PPT will be defined as the arithmetic mean of four consecutive measurements taken at two sites bilaterally: (1) the lumbar paraspinal or gluteal muscle, 2 cm lateral to the spinous process or posterior superior iliac spine of the participant's most painful lumbar segment, and (2) the thumbnail bed.
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Adverse reactions to physical exercise sessions
After each individual exercise sessions, participants will be asked to complete a short questionnaire to assess whether an adverse reaction to physical exercise (yes/no and details) was experienced. This item will also serve to monitor adherence. Data collected in REDCap.
Time frame: Immediately after each PE session (Monday, Thursday, and Weekend for 12 weeks)
Pain related to physical exercise sessions
After each individual exercise sessions, participants will be asked to complete a short questionnaire to assess pain during and after exercise in a 0-10 NRS. Data collected in REDCap.
Time frame: Immediately after each PE session (Monday, Thursday, and Weekend for 12 weeks)
Effort during physical exercise sessions
After each individual exercise sessions, participants will be asked to complete a short questionnaire to assess effort during the exercise in a 0-100 Borg scale. Data collected in REDCap.
Time frame: Immediately after each PE session (Monday, Thursday, and Weekend for 12 weeks)
Fatigue due to physical exercise sessions
After each individual exercise sessions, participants will be asked to complete a short questionnaire to assess fatigue after exercise in a 0-10 NRS. Data collected in REDCap.
Time frame: Immediately after each PE session (Monday, Thursday, and Weekend for 12 weeks)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The study is currently still in a feasibility stage, this will be determined later
Started Jun 2025 (actual). Primary completion is estimated for Dec 2028, 42 months after the start.
Of 877 non-industry interventional studies with no phase under Inflammation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 42 months is above that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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