rTMS and Facet Joint Steroid Injection in Chronic Back Pain
Status:
Not yet recruiting
Trial end date:
2024-01-31
Target enrollment:
Participant gender:
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.