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

Hugo Massé-Alarie1 site in 1 country140 target enrollmentSeptember 25, 2020

ConditionsChronic Low-back Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Low-back Pain
Sponsor: Hugo Massé-Alarie
Enrollment: 140
Locations: 1
Primary Endpoint: Pain intensity (average pain over the last week)
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 25, 2020

End Date

March 1, 2024

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hugo Massé-Alarie

Responsible Party

Sponsor Investigator

Principal Investigator

Hugo Massé-Alarie

Associate Professor, Medicine Faculty, Department of Rehabilitation

Laval University

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.

Outcomes

Primary Outcomes

Pain intensity (average pain over the last week)

Time Frame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks

Pain score on a 11-point pain numerical rating scale (PNRS) ranging from 0 to 10, with 0 meaning no pain and 10 the worst pain imaginable.

Secondary Outcomes

Disability (ODI)(Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks)
Tampa scale of kinesiophobia (TSK)(Change from baseline to 8 weeks, 12 weeks and 24 weeks)
Global rating of change(Change from baseline to 8 weeks)