Clinical trial NCT04555278: Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
Official title: Repetitive Transcranial Magnetic Stimulation Alone and in Combination With Motor Control Exercise for the Treatment of Patients With Chronic Non-specific Low Back Pain (ExTraStim Trial): Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Transcranial Magnetic Stimulation
Motor Control Exercises
Randomized Controlled Trial
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: The Canadian Pain Society
name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-09-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pseudo-factorial design (rTMS: Active/Sham \| Exercises: Yes/No)
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation alone and in combination with motor control exercises on pain and disability for patients with chronic non-specific low back pain.


Eligibility criteria: Inclusion Criteria:

* chronic low back pain, defined as "pain in the low back area with or without leg pain above the knee limiting activities or daily routine which has been present for more than 3 months";
* a minimal average pain intensity of 3 out of 10 during the preceding week on a pain numerical rating scale;
* a minimal score of 10 points on the Oswestry disability index (ODI).

Exclusion Criteria:

* specific spinal pathology (fracture, tumor, radiculopathy, spinal infection, etc.);
* a history of back surgery;
* a major orthopedic, neurological, cardiovascular or psychiatric illness;
* low back pain is not the main pain complaint;
* currently using an exercise program to treat their LBP;
* presenting with any specific TMS/rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, specific medication and pregnancy;
* previous use of repetitive transcranial magnetic stimulation.

Primary outcomes:
measure: Pain intensity (average pain over the last week)
timeFrame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary outcomes:
measure: Disability (ODI)
timeFrame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
measure: Tampa scale of kinesiophobia (TSK)
timeFrame: Change from baseline to 8 weeks, 12 weeks and 24 weeks
measure: Global rating of change
timeFrame: Change from baseline to 8 weeks
Other outcomes:
measure: Brain imaging using MRI metrics
timeFrame: Baseline
Locations:
city: Québec
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:
citation: Patricio P, Roy JS, Macedo L, Roy M, Leonard G, Hodges P, Masse-Alarie H. Repetitive transcranial magnetic stimulation alone and in combination with motor control exercise for the treatment of individuals with chronic non-specific low back pain (ExTraStim trial): study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e045504. doi: 10.1136/bmjopen-2020-045504.