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

Hugo Massé-Alarie

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Other: Motor Control Exercises; Device: Sham rTMS; Device: Active rTMS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04555278

2020-1844

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

Active rTMS + Motor control exercises

Experimental group

Description:

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).

Treatment:

Device: Active rTMS

Other: Motor Control Exercises

Sham rTMS + Motor control exercises

Sham Comparator group

Description:

Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).

Treatment:

Device: Sham rTMS

Other: Motor Control Exercises

Active rTMS

Experimental group

Description:

Active (real) repetitive transcranial magnetic stimulation (20 minutes).

Treatment:

Device: Active rTMS

Sham rTMS

Sham Comparator group

Description:

Sham repetitive transcranial magnetic stimulation (20 minutes).

Treatment:

Device: Sham rTMS