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

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Device: Sham rTMS; Device: Active rTMS; Other: Motor Control Exercises

• Registration Number: NCT04555278
• Lead Sponsor: Hugo Massé-Alarie

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 available

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2020-09-25
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS + Motor control exercises	Sham rTMS	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 rTMS + Motor control exercises	Motor Control Exercises	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 rTMS	Sham rTMS	Sham repetitive transcranial magnetic stimulation (20 minutes).
Active rTMS + Motor control exercises	Active rTMS	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 rTMS + Motor control exercises	Motor Control Exercises	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 rTMS	Active rTMS	Active (real) repetitive transcranial magnetic stimulation (20 minutes).

Primary Outcome Measures

Name	Time	Method
Pain intensity (average pain over the last week)	Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks	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

Name	Time	Method
Disability (ODI)	Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks	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)	Change from baseline to 8 weeks, 12 weeks and 24 weeks	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).
Global rating of change	Change from baseline to 8 weeks	A 11-point scale ranging from -5 to 5, to evaluate the perceived change of health status after the intervention.

Trial Locations

Locations (1)

CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale); 🇨🇦 Québec, Quebec, Canada