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Completed

NCT Number: NCT04555278

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

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1M 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Repetitive Transcranial Magnetic Stimulation

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).

Other names: Sham Repetitive Transcranial Magnetic Stimulation

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.

Primary outcomes

  1. 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

  1. Disability (ODI)

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

    The Oswestry Disability Index (ODI) version 2.1 is a self-completed questionnaire giving a subjective percentage score of disability. Includes 10 questions rated on a 6-item scale, from 0 to 5 points. The total score ranges from "0" (No disability) to "100" (Maximal disability).

  2. Tampa scale of kinesiophobia (TSK)

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

    TSK is used to assess pain-related fear of movement with a 17-item questionnaire. Each item is scored on a 4-point Likert scale. Total score ranges from 17 (minimal pain-related fear of movement) to 58 (maximal pain-related fear of movement).

  3. Global rating of change

    Time frame: Change from baseline to 8 weeks

    A 11-point scale ranging from -5 to 5, to evaluate the perceived change of health status after the intervention.

Other outcomes

  1. Brain imaging using MRI metrics

    Time frame: Baseline

    Resting-state fMRI and diffusion MRI imaging will be acquired on a 3T Philips Scanner (Achieva 3.0T (TX), Philips Healthcare Medical Systems, Best, Netherlands) with an 15-channel head coil.

    Functional and anatomic connection will be assessed between several regions of interest including: the primary motor cortex and the thalamus, the thalamus and the periaqueductal gray, the nucleus accumbens and the medial prefrontal cortex, the uncinate fasciculus.

Sponsors and collaborators

Lead sponsor

Hugo Massé-Alarie

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Pfizer
  • The Canadian Pain Society

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2020
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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