Brain and Gene Expression Responses to Exercise in Chronic Back Pain

NCT07480460 | Completed

• 1 other identifier: CLBPE
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

chronic pain; back pain; physical exercise; inflammation; brain connectivity

Outcome Measures

Primary Outcomes (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."

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

Secondary Outcomes (6)

• Oswestry Low Back Pain Disability Index (ODI)

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

• Nucleus Accumbens-Medial Prefrontal Cortex Functional Connectivity

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

• Whole-Brain Intrinsic Connectivity

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

• Fractional Anisotropy of NAc-mPFC White Matter Tract

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

• Peripheral Blood Gene Expression (RNA Sequencing)

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

Other Outcomes (2)

• Submaximal Aerobic Power (subMAP85%)

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

• Six-Minute Walk Distance

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

Study Arms (2)

Active intervention

EXPERIMENTAL

Physical exercise training

Behavioral: Supervised physical exercise training

Waitlist control

NO INTERVENTION

Participants underwent all assessments but did not receive exercise training during the 14-week study period.

Interventions

Supervised physical exercise training BEHAVIORAL

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

Active intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

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

Montreal, Quebec, H3W 1W4, Canada

Location

Related Publications (7)

• Hird EJ,Slanina-Davies A,Lewis G,Hamer M,Roiser JP

  BACKGROUND

• Jiang R,Geha P,Rosenblatt M,Wang Y,Fu Z,Foster M,Dai W,Calhoun VD,Sui J,Spann MN,Scheinost D

  BACKGROUND

• Geneen LJ,Moore RA,Clarke C,Martin D,Colvin LA,Smith BH

  BACKGROUND

• 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

  BACKGROUND

• Lesnak JB,Berardi G,Sluka KA

  BACKGROUND

• Schwartz N,Temkin P,Jurado S,Lim BK,Heifets BD,Polepalli JS,Malenka RC

  BACKGROUND

• 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.

  PMID: 22751038 BACKGROUND

Related Links

• Study pre-print

MeSH Terms

Conditions

Chronic Pain; Back Pain; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Mechanistic trial

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: March 31, 2017
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)