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

Primary Purpose

Chronic Low-back Pain

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active rTMS
Sham rTMS
Motor Control Exercises
Sponsored by
Hugo Massé-Alarie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Transcranial Magnetic Stimulation, Motor Control Exercises, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Active rTMS + Motor control exercises

Sham rTMS + Motor control exercises

Active rTMS

Sham rTMS

Arm Description

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).

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

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

Sham repetitive transcranial magnetic stimulation (20 minutes).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2020
Last Updated
October 2, 2023
Sponsor
Hugo Massé-Alarie
Collaborators
Pfizer, The Canadian Pain Society, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04555278
Brief Title
Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hugo Massé-Alarie
Collaborators
Pfizer, The Canadian Pain Society, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Transcranial Magnetic Stimulation, Motor Control Exercises, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pseudo-factorial design (rTMS: Active/Sham | Exercises: Yes/No)
Masking
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.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS + Motor control exercises
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham rTMS + Motor control exercises
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).
Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
Active (real) repetitive transcranial magnetic stimulation (20 minutes).
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation (20 minutes).
Intervention Type
Device
Intervention Name(s)
Active rTMS
Other Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Motor Control Exercises
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity (average pain over the last week)
Description
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.
Time Frame
Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Disability (ODI)
Description
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).
Time Frame
Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Title
Tampa scale of kinesiophobia (TSK)
Description
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).
Time Frame
Change from baseline to 8 weeks, 12 weeks and 24 weeks
Title
Quality of life (SF-12)
Description
The SF-12 is a generic quality-of-life questionnaire which consist of twelve questions evaluating eight mental and physical health domains.
Time Frame
Change from baseline to 8 weeks, 12 weeks and 24 weeks
Title
Global rating of change
Description
A 11-point scale ranging from -5 to 5, to evaluate the perceived change of health status after the intervention.
Time Frame
Change from baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Brain imaging using MRI metrics
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Massé-Alarie, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
City
Québec
ZIP/Postal Code
G1M 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33762244
Citation
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.
Results Reference
derived

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

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