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Non-invasive Brain Stimulation

rTMS + Exercise for Chronic Lower Back Pain

N/A

Waitlist Available

Led By Hugo Massé-Alarie, PhD

Research Sponsored by Hugo Massé-Alarie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks

Awards & highlights

Study Summary

This trial will study whether a treatment of repetitive transcranial magnetic stimulation combined with motor control exercises is more effective at reducing pain and disability for patients with chronic non-specific low back pain than either treatment alone.

Who is the study for?

This trial is for adults with chronic non-specific low back pain lasting more than 3 months, experiencing a minimum pain intensity of 3/10 and at least moderate disability. It's not suitable for those with specific spinal conditions, past back surgery, major health issues, TMS contraindications like seizures or pregnancy, prior rTMS use, or who are currently on an exercise program for their back pain.Check my eligibility

What is being tested?

The study tests if repetitive transcranial magnetic stimulation (rTMS), both alone and combined with motor control exercises, can reduce pain and disability in people with chronic lower back pain. Participants will receive either real rTMS or a sham treatment alongside exercises to compare the effects.See study design

What are the potential side effects?

Possible side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases. Motor control exercises might cause temporary muscle soreness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain intensity (average pain over the last week)

Secondary outcome measures

Disability (ODI)

Global rating of change

Quality of life (SF-12)

+1 more

Other outcome measures

Brain imaging using MRI metrics

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Active rTMS + Motor control exercisesExperimental Treatment2 Interventions

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).

Group II: Active rTMSExperimental Treatment1 Intervention

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

Group III: Sham rTMS + Motor control exercisesPlacebo Group2 Interventions

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

Group IV: Sham rTMSPlacebo Group1 Intervention

Sham repetitive transcranial magnetic stimulation (20 minutes).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active rTMS

2019

Completed Phase 2

~350

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Hugo Massé-AlarieLead Sponsor

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,734 Total Patients Enrolled

The Canadian Pain SocietyOTHER

3 Previous Clinical Trials

221 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have volunteered to participate in the current clinical experiment?

"Yes, the information posted on clinicaltrials.gov verifies that this medical experiment is actively searching for volunteers. It was initially announced on September 25th 2020 and most recently updated on August 26th 2022. The trial requires 140 people to be recruited from one single site."

Answered by AI

Are individuals being enrolled in this trial at the present time?

"Affirmative. According to clinicaltrials.gov, this scientific trial is open for recruitment and was first posted on September 25th 2020 with the latest update made on August 26th 2022. The study requires 140 participants from a single site to be enrolled."

Answered by AI

Recent research and studies

BMJ OpenJournal

Repetitive Transcranial Magnetic Stimulation Alone and in Combination with Motor Control Exercise for the Treatment of Individuals with Chronic Non-specific Low Back Pain (extrastim Trial): Study Protocol for a Randomised Controlled Trial

Patricio, Philippe, Jean-Sébastien Roy, Luciana Macedo, Mathieu Roy, Guillaume Léonard, Paul Hodges, and Hugo Massé-Alarie. 2021. “Repetitive Transcranial Magnetic Stimulation Alone and in Combination with Motor Control Exercise for the Treatment of Individuals with Chronic Non-specific Low Back Pain (extrastim Trial): Study Protocol for a Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-045504.

clinicaltrials.govStudy

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

Hugo Massé-Alarie 2020. "Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04555278.