Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Low-back Pain (cLBP)

• Registration Number: NCT06999772
• Lead Sponsor: Laval University

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.

Study Timeline

• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Study Start: 2025-06-16
• Last Update Posted: 2025-06-18
• Primary Completion: 2026-11-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical functioning (ODI)	Baseline, weeks 2, 8 and 26.	The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability). The total score ranges from 0 (no disability) to 100% (maximal disability).

Secondary Outcome Measures

Name	Time	Method
Pain intensity (NPRS)	Baseline, weeks 2, 8 and 26.	The Numerical Pain Rating Scale (NPRS) is an 11-point scale used to measure the mean intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).
Quality of life (EQ-5D-5L)	Baseline, weeks 2, 8 and 26.	The EQ-5D-5L is a self-administrated questionnaire that contains 5 questions, each rated on a 5-point scale and mesuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions define 5\^5 = 3125 possible health states, which can be converted into a Canadian weighted index score. This index score ranges from -0.148 (lowest value assigned to a health state) to 0.949 (highest value assigned to a health state).
Depression symptoms (PHQ)	Baseline, weeks 2, 8 and 26.	The Patient Health Questionnaire is a self-administrated questionnaire of 9 questions used to diagnose depression and grade severity of symptoms. The scale ranges from 0 to 27; a higher score means more depressive symptoms.
Pain catastrophizing (PCS)	Baseline, weeks 2, 8 and 26.	The Pain Catastrophizing Scale (PCS) is a self-administrated questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point scale ranging from 0 (not at all, low level of catastrophizing thoughts) to 5 (all the time, high level of catastrophizing thoughts).
Fear of movement (TSK-13)	Baseline, weeks 2, 8 and 26	The Tampa Scale of Kinesiophobia is a self-administrated questionnaire used to assess fear of movement using 13 questions on a 4-point scale ranging from 1 (strongly disagree, low level of kinesiophobia) to 4 (strongly agree, high level of kinesiophobia).
Self-efficacy (PSEQ-10)	Baseline, weeks 2, 8 and 26.	The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire mesuring the confidence people with ongoing pain have in performing activities while in pain, on a 10-point scale from 0 (not at all confident, low self-efficacy) to 10 (completely confident, high self-efficacy).
Post-traumatic stress disorder (PCL-5)	Baseline, weeks 2, 8 and 26.	The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20-item self-completed questionnaire that assesses the 20 DSM-5 symptoms of post-traumatic stress disorder on a 5-point scale ranging from 0 (not a all, no symptoms of PTSD) to 4 (extremely, severe symptoms of PTSD).
Medication use	Baseline, weeks 2, 8 and 26.	The Medication Quantification Scale Version 4 quantifies the risk weights of the use of 36 drug sub-classes used in pain management. Each drug sub-class has a detriment weight from 0 (low risk weight) to 10(high risk weight). The total score represents the summation of each drug class used by the participant.
Global rating of change (GRC)	Weeks 2, 8 and 26	The Global rating of change (GRC) is a 11-point scale ranging from -5 (a great deal worst) to 5 (a great deal better) to measure the perceived change of health status after the intervention.
Patient Acceptable Symptom State (PASS)	Baseline, weeks 2, 8 and 26.	The Patient Acceptable Symptom State (PASS) measures if the participants consider their current functional and symptoms states as satisfactory or not. A visual analogue scale ranging from 0 (completely dissatisfied) to 100 (completely satsified) is used.

Trial Locations

Locations (1)

Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale); 🇨🇦 Quebec City, Quebec, Canada