RTMS and Steroid Joint Steroid Injection in Chronic Spinal Pain

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

Interventions

DEVICE

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).

DEVICE

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.

Sponsors & Collaborators

• Western University, Canada

  collaborator OTHER

• St. Joseph's Health Care London

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Siobhan Schabrun · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2025-07-31

Completion

2025-12-31

Countries

• Canada

Study Locations