Chronic Low Back Pain (CLBP)eCLBPNCT07497425

Neuroimmune Responses to Exercise in Chronic Back Pain

A study testing Physical Exercise in people with Chronic Low Back Pain (CLBP), run by McGill University at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Low Back Pain (CLBP)
What is being tested?: Physical Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteCanada
Study dates: 1 Jun 2025to 30 Jun 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).
Be over 18 years and under 75 years of age;

Who cannot join

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;

Show all 12Show fewer

Presence of any contraindications to MRI examination (including any metallic implants or devices, being pregnant, and claustrophobia).
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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carlos Gevers Montoro, PhD contact

+1-8199790448

backpain@muhc.mcgill.ca

Canada1 site, 1 recruiting

Montreal General Hospital
Montreal, Quebec, H3H 1V6
Carlos Gevers Montoro, PhD, +1-8199790448, backpain@muhc.mcgill.ca
Recruiting

Other trials in Canada

About this study

Official title: Neuroimmune Responses to Physical Exercise Training in Chronic Primary Low Back Pain

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.

Read the detailed description

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.

Conditions: Chronic Low Back Pain (CLBP)
Being tested: Physical Exercise
Keywords: mechanisms, immune system, inflammation, brain, chronic pain, exercise
Medical subject headings: Inflammation, Chronic Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical ExerciseBehavioural
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.

Study groups in NCT07497425
Study group	Role	What they receive
Active intervention	Experimental	Physical Exercise Training Receives: Behavioral: Physical Exercise
Waitlist	No intervention	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.
Healthy controls	Other	Sex- and age-matched healthy volunteers will only participate in the first 2 weeks of PE intervention Receives: Behavioral: Physical Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, assessed daily through electronic pain diaries.

Secondary outcomes (18)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202530 Jun 2029

First posted27 Mar 2026
Study start1 Jun 2025
Primary completion31 Dec 2028 (estimated)
Study completion30 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Mechanistic clinical trial in which two patient groups are randomized to two parallel arms (physical exercise vs waitlist), and a group of healthy controls are recruited to compare biological variables.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 216 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07497425
Sponsor's protocol ID: eCLBP
Acronym: eCLBP
Status last verified: Aug 2026
First submitted: 16 Mar 2026
Last updated: 19 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The study is currently still in a feasibility stage, this will be determined later

Publications

Kaplan CM, Kelleher E, Irani A, Schrepf A, Clauw DJ, Harte SE. Deciphering nociplastic pain: clinical features, risk factors and potential mechanisms. Nat Rev Neurol. 2024 Jun;20(6):347-363. doi: 10.1038/s41582-024-00966-8. Epub 2024 May 16.
PubMed 38755449
Langston PK, Mathis D. Immunological regulation of skeletal muscle adaptation to exercise. Cell Metab. 2024 Jun 4;36(6):1175-1183. doi: 10.1016/j.cmet.2024.04.001. Epub 2024 Apr 25.
PubMed 38670108
Peake JM, Neubauer O, Della Gatta PA, Nosaka K. Muscle damage and inflammation during recovery from exercise. J Appl Physiol (1985). 2017 Mar 1;122(3):559-570. doi: 10.1152/japplphysiol.00971.2016. Epub 2016 Dec 29.
PubMed 28035017
Leunig A, Gianeselli M, Russo SJ, Swirski FK. Connection and communication between the nervous and immune systems. Nat Rev Immunol. 2025 Dec;25(12):912-933. doi: 10.1038/s41577-025-01199-6. Epub 2025 Jul 10.
PubMed 40640567
Bortsov A, Esfahani SJ, Lima LV, Ji RR, Mogil JS, Diatchenko L. How people resolve pain: insights from human transcriptomics into immune activation and therapeutic innovations. Pain. 2025 Nov 1;166(11S):S60-S64. doi: 10.1097/j.pain.0000000000003671.
PubMed 41086330
Grace PM, Hutchinson MR, Maier SF, Watkins LR. Pathological pain and the neuroimmune interface. Nat Rev Immunol. 2014 Apr;14(4):217-31. doi: 10.1038/nri3621. Epub 2014 Feb 28.
PubMed 24577438
Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
PubMed 34580864
Baliki MN, Petre B, Torbey S, Herrmann KM, Huang L, Schnitzer TJ, Fields HL, Apkarian AV. Corticostriatal functional connectivity predicts transition to chronic back pain. Nat Neurosci. 2012 Jul 1;15(8):1117-9. doi: 10.1038/nn.3153.
PubMed 22751038
Parisien M, Lima LV, Dagostino C, El-Hachem N, Drury GL, Grant AV, Huising J, Verma V, Meloto CB, Silva JR, Dutra GGS, Markova T, Dang H, Tessier PA, Slade GD, Nackley AG, Ghasemlou N, Mogil JS, Allegri M, Diatchenko L. Acute inflammatory response via neutrophil activation protects against the development of chronic pain. Sci Transl Med. 2022 May 11;14(644):eabj9954. doi: 10.1126/scitranslmed.abj9954. Epub 2022 May 11.
PubMed 35544595

Interested in taking part?

Carlos Gevers Montoro, PhD

+1-8199790448

backpain@muhc.mcgill.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Chronic Low Back Pain (CLBP) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuroimmune Responses to Physical Exercise Training in Chronic Primary Low Back Pain
ClinicalTrials.gov ID: NCT07497425
Acronym / sponsor ID: eCLBP / eCLBP
Conditions: Chronic Low Back Pain (CLBP)
Keywords: mechanisms, immune system, inflammation, brain, chronic pain, exercise
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 216 participants (estimated)
Lead sponsor: McGill UniversityUniversity, hospital or other
Study start: 1 Jun 2025 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 30 Jun 2029 (estimated)
First posted: 27 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Mechanistic clinical trial in which two patient groups are randomized to two parallel arms (physical exercise vs waitlist), and a group of healthy controls are recruited to compare biological variables.

Arm	Type	Receives
Active intervention	Experimental	Behavioral: Physical ExercisePhysical Exercise Training
Waitlist	No intervention	–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.
Healthy controls	Other	Behavioral: Physical ExerciseSex- and age-matched healthy volunteers will only participate in the first 2 weeks of PE intervention

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).
Be over 18 years and under 75 years of age;

Key exclusion criteria (12 listed)

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+);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical ExercisePatients 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.	Behavioural	Active intervention, Healthy controls

Primary outcome

Chronic Low Back Pain Intensity
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, assessed daily through electronic pain diaries.
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.

18 secondary outcomes

Peripheral Blood Gene Expression (RNA Sequencing)
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
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Fractional Anisotropy of NAc-mPFC White Matter Tract
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Whole-Brain Intrinsic Connectivity
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Tonic Pain Signature (ToPS)
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Nociplastic Functional Signature (NFS)
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Hippocampal volume
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Superior Longitudinal Fasciculus (SLF) White Matter Integrity
Time frame: MRI acquired at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Heart rate variability: RMSSD
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
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
NIH minimum dataset emotional depression and distress subscale
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
NIH minimum dataset sleep disturbance subscale
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Oswestry Low Back Pain Disability Index (ODI)
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Fatigue severity scale
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Pittsburgh sleep quality index
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Snaith-Hamilton pleasure scale
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Multiple abilities self-assessed questionnaire
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)
Movement-evoked pain
Time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Background: PubMed 38755449Kaplan CM, Kelleher E, Irani A, Schrepf A, Clauw DJ, Harte SE. Deciphering nociplastic pain: clinical features, risk factors and potential mechanisms. Nat Rev Neurol. 2024 Jun;20(6):347-363. doi: 10.1038/s41582-024-00966-8. Epub 2024 May 16.
Background: PubMed 38670108Langston PK, Mathis D. Immunological regulation of skeletal muscle adaptation to exercise. Cell Metab. 2024 Jun 4;36(6):1175-1183. doi: 10.1016/j.cmet.2024.04.001. Epub 2024 Apr 25.
Background: PubMed 28035017Peake JM, Neubauer O, Della Gatta PA, Nosaka K. Muscle damage and inflammation during recovery from exercise. J Appl Physiol (1985). 2017 Mar 1;122(3):559-570. doi: 10.1152/japplphysiol.00971.2016. Epub 2016 Dec 29.
Background: PubMed 40640567Leunig A, Gianeselli M, Russo SJ, Swirski FK. Connection and communication between the nervous and immune systems. Nat Rev Immunol. 2025 Dec;25(12):912-933. doi: 10.1038/s41577-025-01199-6. Epub 2025 Jul 10.
Background: PubMed 41086330Bortsov A, Esfahani SJ, Lima LV, Ji RR, Mogil JS, Diatchenko L. How people resolve pain: insights from human transcriptomics into immune activation and therapeutic innovations. Pain. 2025 Nov 1;166(11S):S60-S64. doi: 10.1097/j.pain.0000000000003671.
Background: PubMed 24577438Grace PM, Hutchinson MR, Maier SF, Watkins LR. Pathological pain and the neuroimmune interface. Nat Rev Immunol. 2014 Apr;14(4):217-31. doi: 10.1038/nri3621. Epub 2014 Feb 28.
Background: PubMed 34580864Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
Background: PubMed 22751038Baliki MN, Petre B, Torbey S, Herrmann KM, Huang L, Schnitzer TJ, Fields HL, Apkarian AV. Corticostriatal functional connectivity predicts transition to chronic back pain. Nat Neurosci. 2012 Jul 1;15(8):1117-9. doi: 10.1038/nn.3153.
Background: PubMed 35544595Parisien M, Lima LV, Dagostino C, El-Hachem N, Drury GL, Grant AV, Huising J, Verma V, Meloto CB, Silva JR, Dutra GGS, Markova T, Dang H, Tessier PA, Slade GD, Nackley AG, Ghasemlou N, Mogil JS, Allegri M, Diatchenko L. Acute inflammatory response via neutrophil activation protects against the development of chronic pain. Sci Transl Med. 2022 May 11;14(644):eabj9954. doi: 10.1126/scitranslmed.abj9954. Epub 2022 May 11.
Individual participant dataSharing planned: Undecided. The study is currently still in a feasibility stage, this will be determined later

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Chronic Low Back Pain (CLBP)
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Carlos Gevers Montoro, PhD contact

+1-8199790448

backpain@muhc.mcgill.ca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Exercise in people with Chronic Low Back Pain (CLBP), run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carlos Gevers Montoro, PhD (+1-8199790448, backpain@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic Low Back Pain Intensity (time frame: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 12). In addition, assessed daily through electronic pain diaries.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497425, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.