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.
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.
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)
Parallel
Magstim Rapid2
Device1-4 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
DeviceSham intervention will follow same protocol as active rTMS using a sham coil that does not deliver actual magnetic stimulation.
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).
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.
Pain Numeric Rating Scale
Pain severity will be assessed at baseline and weekly until week 24 using the 11-point Pain Numeric Rating Scale.
Brief Pain Inventory - Short Form (BPI-SF)
Pain severity and the impact of pain on the patient's daily functioning will be assessed using the 9-item, Brief Pain Inventory short form at baseline, weeks 4, 8, 12, and 24.
12-Item Short Form (SF-12)
The 12-item short form (SF-12) will be used to assess the quality of life and will be taken at baseline, weeks 4, 12 and 24.
Oswestry Disability Index (ODI)
Disability will be assessed using the Oswestry Disability Index (ODI) at baseline, weeks 4, 8, 12, and 24. The 12-item short form (SF-12) will be used to assess the quality of life and will be taken at baseline, weeks 4, 12 and 24. Finally, as rTMS has previously been shown to positively affect depression and anxiety symptoms, the Depression Anxiety and Stress Scale 21 (DASS-21) will be used to monitor any potential effects our rTMS treatment has on mood. This will be administered at weeks 4, 12, and 24.
Click on the lead sponsor to view all of their trials.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
Western University, Canada
Collaborator
St. Joseph's Health Care London
Collaborator
