Repetitive Transcranial Magnetic Stimulation Combined with Steroid Joint Injection for the Treatment of Chronic Spinal Pain: Protocol for a Pilot Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Parkwood Institute (Main Building)
RECRUITING
London
St. Joseph's Health Care London
RECRUITING
London
Contact Information
Primary
Alexandria Roa Agudelo, MLA
alexandria.roaagudelo@sjhc.london.on.ca
519-646-6100
Backup
Keaton Lightfoot, BSc
Keaton.Lightfoot@sjhc.london.on.ca
519-646-6100
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: active repetitive transcranial magnetic stimulation + steroid joint injection
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).
Sham_comparator: sham repetitive transcranial magnetic stimulation + steroid joint injection
The sham repetitive transcranial magnetic stimulation coil will be delivered using a Placebo D70mm Air Film 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.
Related Therapeutic Areas
Sponsors
Collaborators: St. Joseph's Health Care London, Western University, Canada
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov