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Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain

NCT04555278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Chronic Low-back Pain

Interventions

DEVICE

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). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT). Active rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes.

DEVICE

Sham rTMS

A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).

OTHER

Motor Control Exercises

The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • The Canadian Pain Society

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Hugo Massé-Alarie

    lead OTHER

Principal Investigators

  • Hugo Massé-Alarie, PhD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555278 on ClinicalTrials.gov