Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
NCT04555278
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- 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).
- 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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| Descriptive Information | |||||||||
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| 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. | ||||||||
| Condition ICMJE | Chronic Low-back Pain | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Patricio P, Roy JS, Macedo L, Roy M, Léonard G, Hodges P, Massé-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. | ||||||||
* 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 | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Hugo Massé-Alarie, Laval University | ||||||||
| Study Sponsor ICMJE | Hugo Massé-Alarie | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| 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 | |||||||||