rTMS and Facet Joint Steroid Injection in Chronic Back Pain

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Chronic low back pain (CLBP) is one of the most common chronic pain conditions globally. Facet joint injections are a routine treatment option for patients with CLBP that is recalcitrant to other treatments. However, FJI 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 FJI 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 CLBP. However, the literature on rTMS in patients with CLBP is limited and no study has explored rTMS in patients receiving recurrent FJI for pain control.

What is also unclear is the mechanisms through which rTMS might exert therapeutic effects on CLBP. Neuroinflammation has been shown to have a key role in the initiation and maintenance of chronic pain, particularly through the actions of serum pro- and anti-inflammatory proteins.

In this pilot randomized controlled trial study, we'll be investigating if combining rTMS with FJI in CLBP individuals will enhance or prolong the analgesic effects of FJI alone. We'll also be studying the relationship between specific pro- and anti-inflammatory proteins and rTMS/FJI treatment response.

The investigators hypothesize that a combined rTMS and FJI intervention will be feasible, tolerable, and safe and will have larger and longer-lasting effects on CLBP than a sham rTMS and FJI intervention. Further, it is hypothesized that anti-inflammatory proteins, such as IL-4 and IL-9, will be upregulated, and pro-inflammatory proteins, such as IL-6, downregulated, relative to baseline, in response to the active rTMS and FJI intervention but not in response to the sham rTMS and FJI intervention.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: Western University, Canada

Criteria

Inclusion Criteria:

• Pain in the low back region (between the thoracolumbar junction and gluteal fold) of an intensity ≥4 on the pain numerical rating scale in the week prior to their most recent FJI and that has been present for at least 6 months

• Participants must have received at least 2 FJIs within the last 12 months at regular intervals

• Participants taking medication will remain eligible for the study if their pharmacological regimen has remained consistent for the past 3 months and are agreeable to maintain a consistent medication dosage throughout the study period.

Exclusion Criteria:

• Known or suspected serious spinal pathology

• Confirmed fracture or dislocation at the time of the injury

• Had spinal surgery in the past 12 months

• Have history of uncontrolled mental health condition(s)

• Other contraindications to spinal injection, and/or

• Have an inflammatory or autoimmune disease

• Meet any specific rTMS-related exclusion criteria listed on the safety screening questionnaire (S1; Rossi et al., 2008).