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

Официальное название

Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Active rTMS
  A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). Stimulation parameters will be obtained by measuring the motor threshold of the first right interosseous muscle, then the rTMS intensity will be set at 110% of this motor threshold. High frequency (HF) rTMS consisting of 60 trains of 5
• Устройство Sham rTMS
  A sham coil will be used (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS and will be located over the same area (dorso-lateral prefrontal cortex).
• Другое Psychologically-informed physiotherapy (PiP)
  Participants will receive 6 intervention sessions (45 min) over 6 weeks by a physiotherapist. The objective of this intervention is to identify biopsychosocial factors that may impede recovery and to address these factors within the physiotherapist's scope of practice. Physiotherapists will use strategies such as the establishment of common goals and therapeutic alliance, the use of behavior change model, motivational interview, education on pain neurophysiology, gradual exposure to movement and
• Другое Usual physiotherapy
  Participants will receive 6 intervention sessions (45 min) over 8 weeks by a physiotherapist. This is a pragmatic group that aims to represent real-word clinical practice i.e. interventions commonly used in physiotherapy to manage CLBP. All interventions that a physiotherapist can deliver in the province of Quebec will be allowed (e.g. manual therapy, exercises). No training will be provided to better reflect usual clinical practice in physiotherapy.

Первичные конечные точки

• Physical functioning (ODI) [Срок оценки: Baseline, weeks 2, 8 and 26.]

Вторичные конечные точки (10)

• Pain intensity (NPRS) [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Quality of life (EQ-5D-5L) [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Depression symptoms (PHQ) [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Pain catastrophizing (PCS) [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Fear of movement (TSK-13) [Срок оценки: Baseline, weeks 2, 8 and 26]
• Self-efficacy (PSEQ-10) [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Post-traumatic stress disorder (PCL-5) [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Medication use [Срок оценки: Baseline, weeks 2, 8 and 26.]
• Global rating of change (GRC) [Срок оценки: Weeks 2, 8 and 26]
• Patient Acceptable Symptom State (PASS) [Срок оценки: Baseline, weeks 2, 8 and 26.]

Критерии участия

Критерии включения

• 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
• Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS) — Québec
• Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale) — Québec

Публикации

• Dupuis F, Tousignant-Laflamme Y, Marier Deschenes P, Fournier P, Nduwimana I, Ballot O, Loisel L, Pinard AM, Lacombe L, Langevin P, Gaumond A, Roy JS, Masse-Alarie H. Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 26;15:e78952. doi: 10.2196/7895 PMID 41587077

Идентификаторы

NCT: NCT06999772 · 2025-3215 : DLPFC - PiP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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