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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555278
• Other study ID #: 2020-1844
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

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