Chronic Low-back Pain Clinical Trial
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
Verified date | March 2024 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale) | Québec |
Lead Sponsor | Collaborator |
---|---|
Hugo Massé-Alarie | Canadian Institutes of Health Research (CIHR), Pfizer, The Canadian Pain Society |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Brain imaging using MRI metrics | 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. |
Baseline | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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