RTMS and Steroid Joint Steroid Injection in Chronic Spinal Pain

NCT05840354 | Recruiting

• 1 other identifier: SJIrTMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Measures of feasibility and tolerability

  Data for feasibility, tolerability, and safety will be analyzed using descriptive statistics. Feasibility and tolerability will be measured as (1) the time taken to complete the recruitment of 40 participants, (2) the number of sessions attended by each participant, (3) the number of dropouts in each group, (4) the proportion of participants recruited from the total number screened, and (5) the willingness of each participant to undergo therapy on an 11-point numerical rating scale with 'not at all willing' at 0 and 'very willing' at 10 (measured at baseline).

  Through study completion, an average of 24 weeks

• Measures for safety

  Safety will be presented as any adverse reaction reported on verbal questioning at each session. The assessor will record a description of any adverse reactions along with the severity, duration and how the adverse reaction was managed. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported.

  Through study completion, an average of 24 weeks

Secondary Outcomes (6)

• Pain Numeric Rating Scale

  Weeks 1 through 24

• Brief Pain Inventory - Short Form (BPI-SF)

  Weeks 4, 8, 12, 24

• 12-Item Short Form (SF-12)

  Weeks 4, 8, 12, 24

• Oswestry Disability Index (ODI)

  Weeks 4, 8, 12, 24

• Global Rating of Change Scale (GRC)

  Weeks 4 - 24

Study Arms (2)

active repetitive transcranial magnetic stimulation + steroid joint injection

ACTIVE COMPARATOR

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).

Device: Magstim Rapid2

sham repetitive transcranial magnetic stimulation + steroid joint injection

SHAM COMPARATOR

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.

Device: Placebo D70mm Air Film Coil

Interventions

Magstim Rapid2 DEVICE

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).

Also known as: rTMS

active repetitive transcranial magnetic stimulation + steroid joint injection

Placebo D70mm Air Film Coil DEVICE

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

Also known as: sham rTMS

sham repetitive transcranial magnetic stimulation + steroid joint injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• St. Joseph's Health Care London: collaborator

Study Sites (2)

St. Joseph's Health Care London

London, Ontario, N6A4V2, Canada

RECRUITING

Parkwood Institute (Main Building)

London, Ontario, N6C 0A7, Canada

RECRUITING

MeSH Terms

Conditions

Inflammation; Chronic Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Siobhan Schabrun

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandria Roa Agudelo, MLA

CONTACT

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

Keaton Lightfoot, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and William and Lynne Gray Research Chair in Mobility and Activity

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 3, 2023
• Study Start: June 20, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)