Brain Stimulation + Physiotherapy for Low Back Pain

Recruiting at 2 trial locations

Overseen By Hugo Massé-Alarie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Non-musculoskeletal conditions, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist military Veterans with chronic low back pain, which often resists current treatments. It combines a special type of brain stimulation, repetitive transcranial magnetic stimulation (rTMS), with a physiotherapy approach that considers emotional and mental factors. The trial will test whether adding brain stimulation can enhance pain relief and daily functioning. Veterans who have experienced non-specific low back pain for over three months and face significant impacts on daily life may be suitable candidates for this study. As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative treatments that address both the physical and emotional aspects of pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've changed your drug dosage for pain or mental health in the last month.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated. Studies indicate that rTMS usually does not cause serious side effects when used according to current safety guidelines, whether in individuals with brain conditions or healthy participants. Some may experience slight discomfort at the treatment site, but serious issues are rare.

Similarly, psychologically informed physiotherapy (PiP) is considered safe. It combines physical therapy with methods to address the emotional and mental aspects of chronic pain, helping people manage pain better without causing harm.

Both treatments have been used safely in other studies, suggesting they are good options for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for low back pain because they bring a fresh approach to managing this common issue. Unlike traditional methods like medication or standard physiotherapy, these treatments incorporate repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain, potentially altering pain perception. This brain stimulation, combined with psychologically-informed physiotherapy (PiP), might offer a more comprehensive approach by addressing both the physical and psychological aspects of pain. Additionally, comparing active rTMS with sham rTMS helps determine the true effectiveness of the brain stimulation component, potentially leading to more targeted therapies for patients.

What evidence suggests that this trial's treatments could be effective for low back pain?

This trial will compare different treatment approaches for chronic low back pain. Research has shown that repetitive transcranial magnetic stimulation (rTMS), which participants in one arm of this trial may receive, might help reduce chronic low back pain. Studies have found that rTMS can lead to more pain relief compared to fake treatments, although the effects sometimes last only a few weeks. Meanwhile, psychologically informed physiotherapy (PiP), included in all treatment arms of this trial, has proven effective in reducing fear, pain, and disability in people with chronic low back pain. It addresses both the mind and body, helping patients manage their pain and improve their ability to function. Combining rTMS with PiP could potentially enhance these benefits, addressing chronic pain more effectively by targeting both mental and physical aspects. ^{3 5 6 7 8}

Who Is on the Research Team?

Hugo Massé-Alarie, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

This trial is for veterans suffering from chronic low back pain who have not found relief with conventional treatments. Participants should be open to combining non-invasive brain stimulation and new physiotherapy approaches.

Inclusion Criteria

High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool psychosocial subscale

I am between 18 and 65 years old.

I am a veteran with chronic low back pain.

Exclusion Criteria

Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy

Diagnosis of drug or alcohol abuse

My medication dose for pain or mental health hasn't changed in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week intervention program combining rTMS with PiP, PiP alone, or usual physiotherapy

8 weeks

5 visits (in-person) in weeks 1-2, 2 visits (in-person) per week in weeks 3-8

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Follow-up assessments at weeks 2, 8, and 26

What Are the Treatments Tested in This Trial?

Interventions

• Active rTMS
• Psychologically-informed physiotherapy (PiP)
• Sham rTMS

Trial Overview

The study tests if repetitive transcranial magnetic stimulation (rTMS) can boost the benefits of psychologically-informed physiotherapy (PiP) compared to usual care for managing chronic low back pain in veterans.

How Is the Trial Designed?

Group I: Active rTMS + PiP Experimental Treatment 2 Interventions

For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions.

Group II: Usual physiotherapy Active Control 1 Intervention

Participants will attend 6 sessions within 8 weeks (1session /week for 4 weeks, 1 session every 2 weeks between weeks 5-8). Each physiotherapy will last 30-45 min.

Group III: Sham rTMS + PiP Placebo Group 2 Interventions

For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Chronic Pain Centre of Excellence for Canadian Veterans

Collaborator

Foundation for Physical Medicine and Rehabilitation

Collaborator

Trials

7

Recruited

240+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1388245719312799

Evidence-based guidelines on the therapeutic use of ...

Real rTMS produced greater pain reduction than sham stimulation, lasting for three weeks. However, these results were not reproduced to date. A second study ( ...

2.

painphysicianjournal.com

painphysicianjournal.com/current/pdf?article=NzE4OQ%3D%3D&journal=132

Effectiveness of Repetitive Transcranial Magnetic ...

The success rate in low back surgery is variable; failure has been reported in 20% to 40% cases (2). Despite successful disc surgery, a number of patients with ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10198434/

Transcranial magnetic stimulation for the treatment of ...

The studies reviewed suggest the potential benefit in chronic lower back pain symptoms after various rTMS protocols and sites of stimulation.

4.

bmjopen.bmj.com

bmjopen.bmj.com/content/11/3/e045504

Repetitive transcranial magnetic stimulation alone and in ...

This is the first powered randomised controlled trial investigating the effectiveness of repetitive transcranial magnetic stimulation (rTMS) on chronic low back ...

5.

epain.org

epain.org/journal/view.html?doi=10.3344/kjp.2014.27.3.285

Repetitive Transcranial Magnetic Stimulation to Treat ...

Conventional treatment yielded 20-30% pain improvement for 2-3 days. After that period, pain returned to pretreatment levels. The patient ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3656498/

Safety and tolerability of repetitive transcranial magnetic ...

The published data suggest rTMS for the treatment or diagnosis of pathologic positive sensory phenomena appears to be a relatively safe and well-tolerated ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S138824572100763X

Safety of Repetitive Trans-Vertebral Magnetic Stimulation

Self-controlled rTVMS (≤20 Hz and ≤90% intensity) did not induce any serious adverse effects in healthy volunteers and patients with spinal cord disorders.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9879417/

Safety Review for Clinical Application of Repetitive ...

rTMS conforming to the current safety guidelines (Tables 3, 4, 5) can be applied safely to both healthy volunteers and patients with acquired brain diseases ...