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Corticosteroid
rTMS + Facet Joint Injections for Chronic Back Pain
N/A
Recruiting
Led By Siobhan Schabrun
Research Sponsored by Lawson Health Research Institute
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 weeks 4, 8, 12, 24
Awards & highlights
Study Summary
This trial will evaluate if combining brain stimulation with injections for chronic low back pain can provide greater, longer-lasting relief than injections alone.
Who is the study for?
This trial is for individuals at St. Joseph's Health Centre in London, Ontario with chronic spinal pain who've had at least two facet joint injections in the past year and are experiencing significant pain despite treatment. Participants must have been on a stable medication regimen for three months and be able to understand English to give consent.Check my eligibility
What is being tested?
The study tests if combining repetitive transcranial magnetic stimulation (rTMS) with routine facet joint injections (FJI) provides better, longer-lasting relief from chronic spinal pain than FJI alone. It also examines how this combination affects inflammation-related proteins that might influence chronic pain.See study design
What are the potential side effects?
Potential side effects of rTMS may include discomfort or mild headache during or after treatment, lightheadedness, tingling or spasms of facial muscles, and rare risk of seizure. Facet Joint Injection risks include infection, bleeding, increased pain, nerve damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 4, 8, 12, 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measures for safety
Measures of feasibility and tolerability
Secondary outcome measures
12-Item Short Form (SF-12)
Brief Pain Inventory - Short Form (BPI-SF)
Depression Anxiety and Stress Scale 21 (DASS-21)
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: active repetitive transcranial magnetic stimulation + steroid joint injectionActive Control2 Interventions
Active transcranial stimulation will be delivered for a total of 11 sessions. Each session will consist of 40 trains of 5s delivered at 10 Hz, at an intensity of 85% of the resting motor threshold for the first dorsal interosseous muscle and an intertrain interval of 25s (total of 2000 stimulations in a 20-minute session).
The steroid joint injection will be given 1-4 week before rTMS begins. A dose of 0.5mL of 40mg/mL triamcinolone and 0.5mL of 2% lidocaine will be given per joint via spinal needle. The treatment team will determine how many joints will be injected based on their standard clinical assessment. Usually, about 2-4 joints are injected depending on a person's pain presentation. Standard practice is to place the needle in the region of the steroid joint opening, resulting in a peri- +/- intra-articular infusion of the injectate. This project will utilize standard clinical practice without modification.
Group II: sham repetitive transcranial magnetic stimulation + steroid joint injectionPlacebo Group2 Interventions
The sham repetitive transcranial magnetic stimulation coil will be delivered using a sham coil of identical colour, size, and shape as the active rTMS coil. The sham coil uses a magnetic shield that blocks the magnetic field from being delivered to the scalp while producing a similar auditory click during discharge. All other aspects of the rTMS protocol will be identical between the active and sham conditions.
The steroid joint injection will be given 1-4 week before sham rTMS begins and will also follow the same protocol as the active rTMS group.
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Who is running the clinical trial?
St. Joseph's Health Care LondonOTHER
27 Previous Clinical Trials
2,458 Total Patients Enrolled
Western University, CanadaOTHER
239 Previous Clinical Trials
56,881 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,692 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious spine problems like tumors or fractures.I have had 2 steroid injections in my joints in the last year.I had spinal surgery within the last year.I am getting steroid injections for back pain at St. Joseph's in London, Ontario.I have had spinal pain of moderate intensity before my last steroid injection.I have passed the safety screening for rTMS treatment.I have been diagnosed with an inflammatory or autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: active repetitive transcranial magnetic stimulation + steroid joint injection
- Group 2: sham repetitive transcranial magnetic stimulation + steroid joint injection
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for patients to join this research endeavor?
"As gleaned from clinicaltrials.gov, the recruitment for this particular trial has already concluded as of April 22nd 2023. Nonetheless, 335 other studies are currently in search of volunteers to participate."
Answered by AI
What long-term goals are researchers trying to achieve with this medical experiment?
"The primary objectives of this 24 week trial are to assess the safety of a new treatment. Secondary outcomes consist of the Brief Pain Inventory - Short Form (BPI-SF), 12-Item Short Form (SF-12) and Oswestry Disability Index (ODI). Additionally, researchers will use the Depression Anxiety and Stress Scale 21(DASS-21) at 4, 12 and 24 weeks to measure any potential effect on mood from rTMS therapy."
Answered by AI
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