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

NCT04555278

Last updated date
Study Location
CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, , G1M 2S8, Canada
Contact
418 529 9141

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Low-back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Chronic Low-back PainCombining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
NCT04555278
  1. Québec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pseudo-factorial design (rTMS: Active/Sham | Exercises: Yes/No)
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Condition  ICMJE Chronic Low-back Pain
Intervention  ICMJE
  • 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.

    Other Name: Repetitive Transcranial Magnetic Stimulation
  • 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 Name: Sham Repetitive Transcranial Magnetic Stimulation
  • 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.
Study Arms  ICMJE
  • Experimental: Active rTMS + Motor control exercises
    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).
    Interventions:
    • Device: Active rTMS
    • Other: Motor Control Exercises
  • Sham Comparator: Sham rTMS + Motor control exercises
    Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).
    Interventions:
    • Device: Sham rTMS
    • Other: Motor Control Exercises
  • Experimental: Active rTMS
    Active (real) repetitive transcranial magnetic stimulation (20 minutes).
    Intervention: Device: Active rTMS
  • Sham Comparator: Sham rTMS
    Sham repetitive transcranial magnetic stimulation (20 minutes).
    Intervention: Device: Sham rTMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2020)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philippe Patricio418 529 9141[email protected]
Contact: Jean Tittley581 308 5231[email protected]
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04555278
Other Study ID Numbers  ICMJE 2020-1844
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Hugo Massé-Alarie, Laval University
Study Sponsor  ICMJE Hugo Massé-Alarie
Collaborators  ICMJE
  • Pfizer
  • The Canadian Pain Society
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator:Hugo Massé-Alarie, PhDLaval University
PRS Account Laval University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP