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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Device: Active rTMS; Other: Motor Control Exercises; Device: Sham rTMS

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Patricio; Phone Number: 418 529 9141; Email: [email protected]
• Study Contact Backup: Name: Jean Tittley; Phone Number: 581 308 5231; Email: [email protected]

Study Locations

• Canada
  • Québec, Canada, G1M 2S8
    • Recruiting
    • Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
    • Contact: Philippe Patricio, PhD cand.; Phone Number: 418 529-9141; Email: [email protected]
    • Contact: Jean Tittley, MSc; Phone Number: 2478 418 529-9141; Email: [email protected]
    • Sub-Investigator: Philippe Patricio, PhD cand.
    • Sub-Investigator: Jean-Sébastien Roy, PhD
    • Sub-Investigator: Luciana Macedo, PhD
    • Sub-Investigator: Mathieu Roy, PhD
    • Sub-Investigator: Paul Hodges, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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 Names: 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.
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).	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.; 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 Names: Sham Repetitive Transcranial Magnetic Stimulation
EXPERIMENTAL: Active rTMS; Active (real) repetitive transcranial magnetic stimulation (20 minutes).	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 Names: Repetitive Transcranial Magnetic Stimulation
SHAM_COMPARATOR: Sham rTMS; Sham repetitive transcranial magnetic stimulation (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 Names: Sham Repetitive Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability (ODI)	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).	Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Tampa scale of kinesiophobia (TSK)	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).	Change from baseline to 8 weeks, 12 weeks and 24 weeks
Quality of life (SF-12)	The SF-12 is a generic quality-of-life questionnaire which consist of twelve questions evaluating eight mental and physical health domains.	Change from baseline to 8 weeks, 12 weeks and 24 weeks
Global rating of change	A 11-point scale ranging from -5 to 5, to evaluate the perceived change of health status after the intervention.	Change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Hugo Massé-Alarie
• Collaborators: Pfizer; Canadian Institutes of Health Research (CIHR); The Canadian Pain Society

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Transcranial Magnetic Stimulation; Motor Control Exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2020-1844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No