RecruitingNAINTERVENTIONAL

RTMS and Steroid Joint Steroid Injection in Chronic Spinal Pain

This study explores a new way to help people with ongoing back pain. Many people find steroid injections useful, but the pain often returns after a few months. This research investigates whether adding a treatment called repetitive transcranial magnetic stimulation (rTMS) can make the pain relief from steroid injections last longer. rTMS is a non-invasive brain treatment that has shown promise in helping chronic pain. The study will assess if combining rTMS with steroid injections is safe, well-tolerated, and more effective at reducing pain and improving daily life than receiving steroid injections by themselves. It's a pilot study, meaning it's an early look into this potential new approach.

At a glance

Status

Recruiting

Phase

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

20 Jun 2023

Estimated completion

31 Dec 2025

Chronic Spinal Pain

What is this study about?

This research is looking for better ways to help people in the UK who suffer from chronic spinal pain, which is long-lasting pain in the back or neck. Many people with this type of pain have steroid injections to help manage it. While these injections can be very effective, the pain often comes back after a few months, meaning more injections are needed.

Researchers are investigating whether combining these steroid injections with a different kind of treatment called repetitive transcranial magnetic stimulation (rTMS) could provide longer-lasting relief. rTMS uses magnetic pulses to stimulate specific areas of the brain; it's a non-invasive treatment that doesn't involve surgery or medication. Previous studies have shown that rTMS might help with chronic back pain, but it hasn't been studied much in people who regularly receive steroid joint injections.

The main goal of this pilot study is to see if adding rTMS to steroid injections is safe, if people can tolerate it well, and if it makes the pain relief last longer or feel more significant than the injections alone. The researchers believe that this combined approach might be a better option for managing long-term spinal pain.

Key takeaways

Researches new ways to manage long-term spinal pain.
Combines steroid injections with a brain stimulation technique (rTMS).
Aims for longer-lasting pain relief than injections alone.
Is a pilot study to check safety and effectiveness.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and currently receiving regular steroid joint injections for your long-lasting spinal pain at the St. Joseph's Health Centre Pain Clinic. Your pain should be at a moderate level (4 out of 10 or higher) in the week before your most recent injection, and you should have had at least two injections in the past year at regular intervals. Your current pain medication routine should also have been stable for the last three months.

There are also some reasons why you might not be able to join. For example, if you have certain serious spinal problems like a tumour or fracture, or if you've had spinal surgery in the last year. You also need to be able to understand and speak English to give your consent and follow the study instructions. People with specific uncontrolled mental health conditions or certain conditions that would make rTMS unsafe are also not able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you get regular steroid joint injections at St. Joseph's Health Centre's Pain Clinic?
Is your pain usually 4 out of 10 or more before your injections?
Have you had at least two steroid injections in the last year, at regular times?
Has your pain medication been steady for the past three months?
Can you understand and speak English?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive your usual steroid joint injections. In addition, you will receive a series of rTMS treatments (or a dummy version of the treatment) starting about 1 to 4 weeks after your injection. These rTMS treatments will happen 3 times a week for two weeks. During these sessions, you will sit comfortably while a device is placed near your head to deliver magnetic pulses. You'll also have assessments to measure your pain levels and how you're feeling throughout the study.

The total duration of your active involvement with the treatment sessions will be approximately two weeks following your steroid injection. You will be monitored and assessed over a longer period to see how effective the treatment is over time. You will not receive any new medications as part of this study, and you should continue with your current medication regimen.

Potential risks and benefits

Participating in this study might offer the benefit of longer-lasting pain relief from your steroid joint injections, potentially improving your quality of life. However, as with any medical study, there are potential risks. rTMS is generally considered safe, but some people might experience mild side effects like headache or discomfort at the treatment site. The study aims to ensure your safety and comfort at all times. Taking part is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

St. Joseph's Health Care London
Verified postcode
London, Canada· Recruiting
Parkwood Institute (Main Building)
Verified postcode
London, Canada· Recruiting

Common questions

What is rTMS?

rTMS stands for repetitive transcranial magnetic stimulation. It's a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain, and it's being explored for various conditions, including pain.

Is rTMS painful?

Most people find rTMS tolerable. You might feel a tapping sensation on your head during the treatment, and some people report a mild headache afterwards, which usually goes away quickly.

Will I know if I'm getting the real rTMS or the dummy version?

No, this is a 'blinded' study, meaning neither you nor the researchers will know whether you are receiving the active rTMS or a 'sham' (dummy) treatment. This helps ensure the results are fair.

How long does each rTMS session last?

The study mentions a 2-week induction phase with treatments 3 times each week. The exact length of each session would be explained by the study team.

What happens if my pain gets worse during the study?

Your safety and well-being are paramount. You will be monitored throughout the study, and you can discuss any concerns or changes in your pain with the study team at any time. You can also withdraw from the study if needed.

How to find out more

Alexandria Roa Agudelo, MLA

alexandria.roaagudelo@sjhc.london.on.ca 519-646-6100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.