NCT05840354 RTMS and Steroid Joint Steroid Injection in Chronic Spinal Pain
| NCT ID | NCT05840354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Chronic Spinal Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-06-20 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic spinal pain (CSP) is one of the most common chronic pain conditions globally. Steroid joint injections (SJI) are a routine treatment option for patients with CLBP that is recalcitrant to other treatments. However, SJI has been shown to have limited long-term efficacy with patients often requiring another injection within months to adequately control pain. One option to prolong the analgesic effects of SJI is to use a type of noninvasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS). Previous studies have shown rTMS may be capable of providing long-term pain relief in patients with chronic back pain. However, the literature on rTMS in patients with CSP is limited and no study has explored rTMS in patients receiving recurrent SJI for pain control. In this pilot randomized controlled trial study, we'll be investigating if combining rTMS with SJI in CSP individuals will enhance or prolong the analgesic effects of SJI alone. The investigators hypothesize that a combined rTMS and SJI intervention will be feasible, tolerable, and safe and will have larger and longer-lasting effects on CSP than a sham rTMS and SJI intervention.
Eligibility Criteria
Inclusion Criteria: * Currently receiving recurrent steroid joint injections for control of chronic spinal pain at the St. Joseph's Health Centre Pain Clinic in London, Ontario, Canada, * Have pain in the spinal region of an intensity ≥4 out of 10 in the week before your most recent steroid joint injection, * Have received at least 2 steroid joint injections within the last 12 months at regular intervals * Have had a consistent medication regimen for the past 3 months. Exclusion Criteria: * Unable to read, understand, and speak English and are not able to give consent * Known or suspected serious spinal pathology (tumour, fracture, dislocation, scoliosis) * Spinal surgery in the past 12 months * History of uncontrolled mental health condition(s) * Meet any specific rTMS-related exclusion criteria listed on the safety screening questionnaire (S1; Rossi et al., 2008).
Contact & Investigator
Siobhan Schabrun
PRINCIPAL INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Frequently Asked Questions
Who can join the NCT05840354 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Spinal Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05840354 currently recruiting?
Yes, NCT05840354 is actively recruiting participants. Contact the research team at alexandria.roaagudelo@sjhc.london.on.ca for enrollment information.
Where is the NCT05840354 trial being conducted?
This trial is being conducted at London, Canada, London, Canada.
Who is sponsoring the NCT05840354 clinical trial?
NCT05840354 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Siobhan Schabrun at London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The trial plans to enroll 40 participants.