Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 3:50 AM
Study NCT ID:
NCT07480460
Status:
COMPLETED
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain and Gene Expression Responses to Exercise in Chronic Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Mechanistic trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Submaximal Aerobic Power (subMAP85%)', 'timeFrame': 'Assessed at Baseline (Week 0) and Post-intervention (Week 14)', 'description': 'Submaximal aerobic power assessed during a graded exercise test at 85% of estimated maximal capacity. Measured in watts (W).'}, {'measure': 'Six-Minute Walk Distance', 'timeFrame': 'Assessed at Baseline (Week 0) and Post-intervention (Week 14)', 'description': 'Functional exercise capacity measured using the 6-Minute Walk Test (6MWT). Distance walked in meters during 6 minutes was recorded.'}], 'primaryOutcomes': [{'measure': 'Chronic Low Back Pain Intensity', 'timeFrame': 'Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 14)', 'description': '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."'}], 'secondaryOutcomes': [{'measure': 'Oswestry Low Back Pain Disability Index (ODI)', 'timeFrame': 'Assessed at Baseline (Week 0) and Post-intervention (Week 14)', 'description': '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.'}, {'measure': 'Nucleus Accumbens-Medial Prefrontal Cortex Functional Connectivity', 'timeFrame': 'MRI acquired at Baseline (Week 0) and Post-intervention (Week 14)', 'description': '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.'}, {'measure': 'Whole-Brain Intrinsic Connectivity', 'timeFrame': 'MRI acquired at Baseline (Week 0) and Post-intervention (Week 14)', 'description': 'Intrinsic connectivity analysis (voxel-wise network centrality; root mean square of all connections) performed using resting-state fMRI.'}, {'measure': 'Fractional Anisotropy of NAc-mPFC White Matter Tract', 'timeFrame': 'MRI acquired at Baseline (Week 0) and Post-intervention (Week 14)', 'description': 'Fractional Anisotropy (FA) measured using diffusion-weighted imaging (DWI) probabilistic tractography along the white matter tract connecting the nucleus accumbens and medial prefrontal cortex.'}, {'measure': 'Peripheral Blood Gene Expression (RNA Sequencing)', 'timeFrame': 'Blood samples collected prior to Session 7 (first calibrated-intensity session, Week 3) and prior to Session 42 (final session, Week 14)', 'description': 'Gene expression levels assessed in peripheral blood immune cells using RNA sequencing (DESeq2 analysis). Transcriptomic analyses evaluated differential gene expression and pathway enrichment.'}, {'measure': 'Plasma Brain-Derived Neurotrophic Factor (BDNF)', 'timeFrame': 'Collected immediately before and after Session 7 (Week 3) and immediately before and after Session 42 (Week 14)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'back pain', 'physical exercise', 'inflammation', 'brain connectivity'], 'conditions': ['Chronic Low Back Pain (CLBP)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Hird EJ,Slanina-Davies A,Lewis G,Hamer M,Roiser JP'}, {'type': 'BACKGROUND', 'citation': 'Jiang R,Geha P,Rosenblatt M,Wang Y,Fu Z,Foster M,Dai W,Calhoun VD,Sui J,Spann MN,Scheinost D'}, {'type': 'BACKGROUND', 'citation': 'Geneen LJ,Moore RA,Clarke C,Martin D,Colvin LA,Smith BH'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': 'Lesnak JB,Berardi G,Sluka KA'}, {'type': 'BACKGROUND', 'citation': 'Schwartz N,Temkin P,Jurado S,Lim BK,Heifets BD,Polepalli JS,Malenka RC'}, {'pmid': '22751038', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://osf.io/preprints/osf/9jhcq_v1', 'label': 'Study pre-print'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nParticipants were randomized to either:\n\n* Supervised exercise training (3 sessions per week, 60 minutes per session, 14 weeks), or\n* Wait-list control.\n\nExercise sessions combined aerobic and resistance training. Exercise intensity was individually calibrated based on VO2max and 1 repetition maximum (1RM) assessments.\n\nAssessments conducted pre- and post-intervention included:\n\n* Resting-state functional MRI\n* Diffusion-weighted imaging\n* Self-reported pain and disability questionnaires\n* Cardiorespiratory and functional testing\n* Blood sampling for BDNF and RNA sequencing\n\nThe 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.\n\nNote: 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Chronic low back pain ≥ 3 months\n* Pain present at least half the days over the past 6 months\n* Average pain intensity ≥ 3/10 during week prior to enrollment\n\nExclusion Criteria:\n\n* Diabetes\n* Neurological disorder\n* Psychiatric disorder\n* Significant cardiorespiratory disease\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT07480460', 'acronym': 'CLBPE', 'briefTitle': 'Brain and Gene Expression Responses to Exercise in Chronic Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Frontostriatal Connectivity and Gene Expression in Exercise-induced Relief of Back Pain', 'orgStudyIdInfo': {'id': 'CLBPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active intervention', 'description': 'Physical exercise training', 'interventionNames': ['Behavioral: Supervised physical exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants underwent all assessments but did not receive exercise training during the 14-week study period.'}], 'interventions': [{'name': 'Supervised physical exercise training', 'type': 'BEHAVIORAL', 'description': '60-minute sessions 3 times weekly Aerobic + resistance training Individually calibrated intensity (VO2max, 1RM) Total duration: 14 weeks', 'armGroupLabels': ['Active intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3W 1W4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mathieu Roy', 'investigatorAffiliation': 'McGill University'}}}}