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

NCT04555278 | Completed

• 1 other identifier: 2020-1844
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Transcranial Magnetic Stimulation; Motor Control Exercises; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity (average pain over the last week)

  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.

  Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Brain imaging using MRI metrics

  Baseline

Study Arms (4)

Active rTMS + Motor control exercises

EXPERIMENTAL

Active (real) repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).

Device: Active rTMS; Other: Motor Control Exercises

Sham rTMS + Motor control exercises

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).

Device: Sham rTMS; Other: Motor Control Exercises

Active rTMS

EXPERIMENTAL

Active (real) repetitive transcranial magnetic stimulation (20 minutes).

Device: Active rTMS

Sham rTMS

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation (20 minutes).

Device: Sham rTMS

Interventions

Active rTMS DEVICE

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.

Also known as: Repetitive Transcranial Magnetic Stimulation

Active rTMS; Active rTMS + Motor control exercises

Sham rTMS DEVICE

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).

Also known as: Sham Repetitive Transcranial Magnetic Stimulation

Sham rTMS; Sham rTMS + Motor control exercises

Motor Control Exercises OTHER

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.

Active rTMS + Motor control exercises; Sham rTMS + Motor control exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• previous use of repetitive transcranial magnetic stimulation.

Sponsors & Collaborators

• Hugo Massé-Alarie: lead
• Pfizer: collaborator
• The Canadian Pain Society: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (2)

• Patricio P, Tittley J, Lucas de Oliveira FC, Roy M, Fakhry N, Macedo LG, Hodges PW, Leonard G, Roy JS, Masse-Alarie H. Repetitive Transcranial Magnetic Stimulation and Motor Control Exercise for Chronic Low Back Pain: The ExTraStim Randomized Placebo-Controlled Trial. J Orthop Sports Phys Ther. 2026 Jan;56(1):1-10. doi: 10.2519/jospt.2025.13681.

  PMID: 41385357 RESULT

• 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.

  PMID: 33762244 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Hugo Massé-Alarie, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to rTMS intervention (real or sham) but cannot be blinded to the exercise intervention. However, participants will not be aware of the study design (other arms). Therapist delivering the exercise intervention will be masked to rTMS intervention (active vs. sham) but cannot be blinded to exercise intervention (yes vs. no). Experimenter delivering the rTMS intervention will be masked to exercise intervention but not to rTMS intervention (real or sham). Outcomes assessor will be completely masked to all interventions as all outcomes are questionnaires that will be completed online. Data will be de-identified and the data analyst will be masked to participants and group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Medicine Faculty, Department of Rehabilitation

Model Details: Pseudo-factorial design (rTMS: Active/Sham \| Exercises: Yes/No)

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: September 25, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)