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Chronic Low Back Pain (CLBP)CLBPENCT07480460

Brain and Gene Expression Responses to Exercise in Chronic Back Pain

A study testing Supervised physical exercise training in people with Chronic Low Back Pain (CLBP), run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is registered retrospectively for transparency. This mechanistic randomized controlled trial examined whether a 14-week supervised physical exercise training program reduces chronic low back pain (CLBP) by modulating frontostriatal brain connectivity and immune-related gene expression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Low Back Pain (CLBP)
What is being tested?
Supervised physical exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteCanada
Study dates
31 Mar 2017to 14 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Chronic low back pain ≥ 3 months
  • Pain present at least half the days over the past 6 months
  • Average pain intensity ≥ 3/10 during week prior to enrollment

Who cannot join

  • Diabetes
  • Neurological disorder
  • Psychiatric disorder
  • Significant cardiorespiratory disease
  • Under 18 years of age

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal

    Montreal, Quebec, H3W 1W4

Other trials in Canada

About this study

Official title: Frontostriatal Connectivity and Gene Expression in Exercise-induced Relief of Back Pain

This study is registered retrospectively for transparency. This mechanistic randomized controlled trial examined whether a 14-week supervised physical exercise training program reduces chronic low back pain (CLBP) by modulating frontostriatal brain connectivity and immune-related gene expression. Fifty-seven adults with CLBP were randomized to exercise training or wait-list control. Participants underwent pre- and post-intervention MRI, questionnaires, and blood sampling. The study tested whether reductions in nucleus accumbens-medial prefrontal cortex connectivity and changes in inflammatory gene expression mediated exercise-induced pain relief.

Read the detailed description

Chronic low back pain (CLBP) is associated with altered functional connectivity between the nucleus accumbens (NAc) and medial prefrontal cortex (mPFC), as well as systemic low-grade inflammation.

This mechanistic randomized controlled trial evaluated the effects of a 14-week supervised physical exercise (PE) training program on pain intensity, functional disability, brain connectivity, and peripheral gene expression in individuals with CLBP.

Participants were randomized to either:

  • Supervised exercise training (3 sessions per week, 60 minutes per session, 14 weeks), or
  • Wait-list control.

Exercise sessions combined aerobic and resistance training. Exercise intensity was individually calibrated based on VO2max and 1 repetition maximum (1RM) assessments.

Assessments conducted pre- and post-intervention included:

  • Resting-state functional MRI
  • Diffusion-weighted imaging
  • Self-reported pain and disability questionnaires
  • Cardiorespiratory and functional testing
  • Blood sampling for BDNF and RNA sequencing

The primary mechanistic hypothesis tested whether changes in NAc-mPFC connectivity and immune-related gene expression mediated exercise-induced reductions in chronic pain. Therefore, primary outcomes focused on indices of target engagement (including immune gene expression and brain connectivity) rather than clinical efficacy alone.

Note: This study was not registered prior to participant enrolment. The project was investigator-initiated and conceived as a mechanistic investigation prior to widespread mandatory registration requirements. Study recruitment and progress were also substantially influenced by the COVID-19 pandemic and associated lockdowns.

The clinical efficacy of PE for CLBP is already well established. Consequently, the primary aim of the present study was to examine the biological mechanisms through which PE may influence pain. Registration is therefore being completed retrospectively to ensure transparency.

Being tested
Supervised physical exercise training
Keywords
chronic pain, back pain, physical exercise, inflammation, brain connectivity
Medical subject headings
Chronic Pain, Back Pain, Motor Activity, Inflammation

What participants receive

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

  • Supervised physical exercise trainingBehavioural

    60-minute sessions 3 times weekly Aerobic + resistance training Individually calibrated intensity (VO2max, 1RM) Total duration: 14 weeks

Study groups in NCT07480460
Study groupRoleWhat they receive
Active interventionExperimentalPhysical exercise training
Receives: Behavioral: Supervised physical exercise training
Waitlist controlNo interventionParticipants underwent all assessments but did not receive exercise training during the 14-week study period.

What is being measured

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

  1. Chronic Low Back Pain Intensity

    Self-reported average low back pain intensity measured using an 11-point Numerical Rating Scale (NRS; 0-10), where 0 = "no pain" and 10 = "worst imaginable pain."

    Measured: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 14)

Secondary outcomes (6)

  1. 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.

    Measured: Assessed at Baseline (Week 0) and Post-intervention (Week 14)

  2. Nucleus Accumbens-Medial Prefrontal Cortex Functional Connectivity

    Functional connectivity assessed using resting-state functional magnetic resonance imaging (rsfMRI). Seed-to-voxel analyses were performed using anatomically defined bilateral nucleus accumbens and medial prefrontal cortex regions.

    Measured: MRI acquired at Baseline (Week 0) and Post-intervention (Week 14)

  3. Whole-Brain Intrinsic Connectivity

    Intrinsic connectivity analysis (voxel-wise network centrality; root mean square of all connections) performed using resting-state fMRI.

    Measured: MRI acquired at Baseline (Week 0) and Post-intervention (Week 14)

  4. Fractional Anisotropy of NAc-mPFC White Matter Tract

    Fractional Anisotropy (FA) measured using diffusion-weighted imaging (DWI) probabilistic tractography along the white matter tract connecting the nucleus accumbens and medial prefrontal cortex.

    Measured: MRI acquired at Baseline (Week 0) and Post-intervention (Week 14)

  5. Peripheral Blood Gene Expression (RNA Sequencing)

    Gene expression levels assessed in peripheral blood immune cells using RNA sequencing (DESeq2 analysis). Transcriptomic analyses evaluated differential gene expression and pathway enrichment.

    Measured: Blood samples collected prior to Session 7 (first calibrated-intensity session, Week 3) and prior to Session 42 (final session, Week 14)

  6. Plasma Brain-Derived Neurotrophic Factor (BDNF)

    Plasma BDNF concentrations measured using Luminex multiplex assay (Human ProcartaPlex). The purpose of this outcome is to evaluate both acute and longer-term neurotrophic responses to exercise training. Acute changes were measured before and after high-intensity training sessions; long-term changes were assessed by comparing baseline levels across sessions.

    Measured: Collected immediately before and after Session 7 (Week 3) and immediately before and after Session 42 (Week 14)

Timeline

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

  1. First posted18 Mar 2026
  2. Study start31 Mar 2017
  3. Primary completion14 Dec 2021
  4. Study completion14 Dec 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Mechanistic trial
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07480460
Sponsor's protocol ID
CLBPE
Acronym
CLBPE
Status last verified
Mar 2026
First submitted
14 Mar 2026
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hird EJ, Slanina-Davies A, Lewis G, Hamer M, Roiser JP. From movement to motivation: a proposed framework to understand the antidepressant effect of exercise. Transl Psychiatry. 2024 Jul 4;14(1):273. doi: 10.1038/s41398-024-02922-y.

    PubMed 38961071

  • Jiang R, Geha P, Rosenblatt M, Wang Y, Fu Z, Foster M, Dai W, Calhoun VD, Sui J, Spann MN, Scheinost D. The inflammatory and genetic mechanisms underlying the cumulative effect of co-occurring pain conditions on depression. Sci Adv. 2025 Apr 4;11(14):eadt1083. doi: 10.1126/sciadv.adt1083. Epub 2025 Apr 2.

    PubMed 40173244

  • Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Jan 14;1(1):CD011279. doi: 10.1002/14651858.CD011279.pub2.

    PubMed 28087891

  • 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

  • Lesnak JB, Berardi G, Sluka KA. Influence of routine exercise on the peripheral immune system to prevent and alleviate pain. Neurobiol Pain. 2023 Mar 21;13:100126. doi: 10.1016/j.ynpai.2023.100126. eCollection 2023 Jan-Jul.

    PubMed 37179769

  • Schwartz N, Temkin P, Jurado S, Lim BK, Heifets BD, Polepalli JS, Malenka RC. Chronic pain. Decreased motivation during chronic pain requires long-term depression in the nucleus accumbens. Science. 2014 Aug 1;345(6196):535-42. doi: 10.1126/science.1253994.

    PubMed 25082697

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Supervised physical exercise training 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 14)). 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 NCT07480460, which also lists 7 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 18 Mar 2026.

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