Clinical trial NCT06999772: Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain
Official title: Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Non-invasive brain stimulation
comorbid psychological risk factors
chronic pain
repetitive transcranial magnetic stimulation
physiotherapy
pyschologically-informed
veterans
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Chronic Pain Centre of Excellence for Canadian Veterans
name: Foundation for Physical Medicine and Rehabilitation
First posted: 2025-05-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind, parallel-group, monocentric, randomised controlled trial (RCT).
Primary purpose: TREATMENT

Brief summary: Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.

Detailed description: The study will compare the effects of (1) combining rTMS with PiP, (2) PiP alone (+sham rTMS), and (3) usual physiotherapy (UP) on physical functioning in Veterans suffering from CLBP and comorbid psychological factors associated with back pain. Participants will undergo an 8-week intervention program. Validated questionnaires will be used to measure outcomes at baseline, 2-, 8-, and 26-week follow-ups. The main objective is to determine if the combination of PiP and rTMS is superior to PiP and UP alone to improve physical functioning in Veterans suffering from CLBP and comorbid psychological factors.

The secondary objectives are to compare the effectiveness of these interventions on secondary outcomes, that are, pain intensity, quality of life, movement pain-related fear, pain catastrophizing, self-efficacy, depression symptoms, medication use and post-traumatic stress disorder symptoms.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 65 years old
* Military Veterans with non-specific chronic low back pain (\> 3 months, \> 50% of the days in the last 6 months)
* High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool psychosocial subscale
* Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)

Exclusion Criteria:

* Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, fracture)
* Diagnosis of drug or alcohol abuse
* Change of drug dosage in the last month for the treatment of pain or mental health
* Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy

Primary outcomes:
measure: Physical functioning (ODI)
timeFrame: Baseline, weeks 2, 8 and 26.
Secondary outcomes:
measure: Pain intensity (NPRS)
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Quality of life (EQ-5D-5L)
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Depression symptoms (PHQ)
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Pain catastrophizing (PCS)
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Fear of movement (TSK-13)
timeFrame: Baseline, weeks 2, 8 and 26
measure: Self-efficacy (PSEQ-10)
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Post-traumatic stress disorder (PCL-5)
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Medication use
timeFrame: Baseline, weeks 2, 8 and 26.
measure: Global rating of change (GRC)
timeFrame: Weeks 2, 8 and 26
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Baseline, weeks 2, 8 and 26.
Other outcomes:
measure: Adverse events
timeFrame: Weeks 2, and 8
Locations:
city: Quebec City
country: Canada
facility: Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
state: Quebec
Study officials:
affiliation: Laval University
name: Hugo Massé-Alarie, PhD
role: PRINCIPAL_INVESTIGATOR
References: