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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04555278
Other study ID # 2020-1844
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2020
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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:
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.

Locations

Country Name City State
Canada CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale) Québec

Sponsors (4)

Lead Sponsor Collaborator
Hugo Massé-Alarie Canadian Institutes of Health Research (CIHR), Pfizer, The Canadian Pain Society

Country where clinical trial is conducted

Canada, 

Outcome

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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