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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaval University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Active rTMS
  • Sham rTMS
  • Psychologically-informed physiotherapy (PiP)
  • Usual physiotherapy

Treatment groups

96 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Laval University

Lead sponsor

Chronic Pain Centre of Excellence for Canadian Veterans

Collaborator

Foundation for Physical Medicine and Rehabilitation

Collaborator