Objective: To inform feasibility and design of a future randomised controlled trial (RCT) using brain functional MRI (fMRI) to determine the mechanism of action of gabapentin in managing chronic pelvic pain (CPP) in women.
Design: Mechanistic study embedded in pilot RCT.
Setting: University Hospital.
Participants: Twelve women (18-50 years) with CPP and no pelvic pathology (follow-up completed March 2014).
Intervention: Oral gabapentin (300-2700 mg) or matched placebo.
Outcome measures: After 12 weeks of treatment, participants underwent fMRI of the brain (Verio Siemens 3T MRI) during which noxious heat and punctate stimuli were delivered to the pelvis and arm. Outcome measures included pain (visual analogue scale), blood oxygen level dependent signal change and a semi-structured acceptability questionnaire at study completion prior to unblinding.
Results: Full datasets were obtained for 11 participants. Following noxious heat to the abdomen, the gabapentin group (GG) had lower pain scores (Mean: 3.8 [SD 2.2]) than the placebo group (PG) (Mean: 5.8 [SD 0.9]). This was also the case for noxious heat to the arm with the GG having lower pain scores (Mean: 2.6 [SD 2.5]) than the PG (Mean: 6.2 [SD 1.1]). Seven out of 12 participants completed the acceptability questionnaire. 71% (five out of seven) described their participation in the fMRI study as positive; the remaining two rated it as a negative experience.
Conclusions: Incorporating brain fMRI in a future RCT to determine the mechanism of action of gabapentin in managing CPP in women was feasible and acceptable to most women.
Trial registration number: ISRCTN70960777.
Keywords: Gabapentin; chronic pelvic pain; functional magnetic resonance imaging (fMRI); pilot randomised control trial (RCT); pilot study; placebo.
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.