Recruiting

rTMS & SJI

Sponsor:

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

Code:

NCT05840354

Conditions

Chronic Spinal Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magstim Rapid2

Placebo D70mm Air Film Coil

Study Details

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.

Conditions

Chronic Spinal Pain

Study ID

NCT05840354

Start date

Jun 20, 2023

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Magstim Rapid2

1-4 weeks after administration of the SJI, participants will attend their first rTMS session. rTMS will be delivered using a biphasic stimulator (DuoMag) and a figure-of-eight coil to the corticomotor representation of the first dorsal interosseous muscle contralateral to the side of worst pain. Recording electrodes will be positioned in a belly-tendon montage over the FDI for electromyography recording. The hotspot and resting motor threshold (rMT) of the FDI will be determined and saved using a Brainsight Neuronavigation system to ensure accurate coil repositioning within and between sessions.

The hotspot and rMT will be confirmed and adjusted if needed at each intervention session. Each rTMS session will consist of 40 trains of 5s delivered at 10Hz, at an intensity of 85% of the resting motor threshold for the FDI muscle and an intertrain interval of 25s (total of 2000 stimulations in a 20-minute session).

Placebo D70mm Air Film Coil

Sham intervention will follow same protocol as active rTMS using a sham coil that does not deliver actual magnetic stimulation.

Primary outcome measure

  • Measures of feasibility and tolerability [ Time Frame: Through study completion, an average of 24 weeks ]
  • Measures for safety [ Time Frame: Through study completion, an average of 24 weeks ]

Central Contacts and Locations

Central contacts

Alexandria Roa Agudelo, MLA

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

Keaton Lightfoot, BSc

519-646-6100Keaton.Lightfoot@sjhc.london.on.ca

Locations

St. Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6A4V2

Contacts

Alexandria Roa Agudelo, MLA

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

Parkwood Institute (Main Building)

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Alexandria Roa Agudelo, MLA

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

More Information

Sponsor

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

Last update posted

Feb 5, 2025

Last verified

Jan, 2025

Keywords

  • repetitive transcranial magnetic stimulation
  • steroid joint injection
  • inflammatory markers
  • inflammation
  • chronic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-02-05.