Dataset Information

The use of brain functional magnetic resonance imaging to determine the mechanism of action of gabapentin in managing chronic pelvic pain in women: a pilot study.

ABSTRACT:

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.

SUBMITTER: Seretny M

PROVIDER: S-EPMC6597644 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The use of brain functional magnetic resonance imaging to determine the mechanism of action of gabapentin in managing chronic pelvic pain in women: a pilot study.

Seretny Marta M Murray Sarah Rose SR Whitaker Lucy L Murnane Jonathan J Whalley Heather H Pernet Cyril C Horne Andrew W AW

BMJ open 20190627 6

<h4>Objective</h4>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.<h4>Design</h4>Mechanistic study embedded in pilot RCT.<h4>Setting</h4>University Hospital.<h4>Participants</h4>Twelve women (18-50 years) with CPP and no pelvic pathology (follow-up completed March 2014).<h4>Intervention</h4>Oral gabapentin (300-2700 mg) or matched plac ...[more]

PMID: 31248918

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Project description:IntroductionGabapentin has potential analgesic benefits in patients with neuropathic pain, such as post-herpetic neuralgia and diabetic peripheral neuropathy neuropathic pain. However, its efficacy in women with chronic pelvic pain (CPP) remains contradictory. In the present study, we performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to ascertain the efficacy of this treatment.MethodsWe systematically reviewed RCTs published in PubMed, Embase, the Cochrane Library, Web of Science, and Google Scholar databases, up to July 2021. These articles compared gabapentin with placebo or any other active treatment for CPP in women, with 'the change in pain scores from the baseline during the first 3 and 6 months of treatment' taken as the primary outcome. We considered reductions equivalent to 1.0 cm for primary outcomes to be clinically important.ResultsFour studies, comprising 469 participants, were included in our meta-analysis. Results revealed that the gabapentin group had significantly higher change in pain intensity scores from baseline to 3 months [weighted mean difference (WMD) - 0.61 cm; 95% confidence interval (CI) - 0.97 to - 0.25; I2 = 0%; p = 0.0009] and 6 months (WMD - 1.38 cm; 95% CI - 1.89 to - 0.88; I2 = 0%; p < 0.00001), relative to the control group. The difference of 6-month pooled result was more clinically important. Results from analysis of secondary outcomes showed that gabapentin had no beneficial efficacy during the first 3 months of treatment. Although gabapentin treatment was associated with a higher risk of dizziness and somnolence, no statistically significant differences were observed with regards to the total incidence of adverse events.ConclusionsOverall, gabapentin could be a potential treatment option for CPP in women. However, as a pilot study, further studies are needed to explore the longer-term benefits and definite safety of this therapy in the future.Registration numberPROSPERO registration number CRD42021249421.

Project description:BackgroundChronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology.MethodsWe performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762.FindingsParticipants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group.InterpretationThis study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology.FundingNational Institute for Health Research.

Project description:BackgroundTo determine the effect of hydration as well as prone versus supine positioning on the pelvic veins during cardiovascular magnetic resonance (CMR) venography.MethodsUnder institutional review board approval, 8 healthy subjects were imaged with balanced steady state free precession, non-contrast CMR venography to measure common and external iliac vein volumes and common femoral vein cross-sectional area in the supine, prone and decubitus positions after dehydration and again following re-hydration. CMR venography from 23 patients imaged both supine and prone were retrospectively reviewed and measurements of common femoral and iliac veins areas were compared using Wilcoxon test.ResultsCommon femoral vein area on CMR venography increased with prone positioning (83?±?35 mm2) compared to supine positioning (59?±?21 mm2) (p?=?0.02) and further increased with hydration to 123?±?44 mm2 (p?<?0.01). With right and left side down decubitus positioning, the common femoral vein area on dehydration increased from 29?±?17 mm2 in the ante-dependent position to 134?±?36 mm2 in the dependent position (p?<?0. 001). Similarly, common and external iliac veins increased in volume with prone, 5.4?±?1.9 cm3 and 5.8?±?1.9 cm3 compared to supine positioning 4.6?±?1.8 cm3 and 4.5?±?1.9 cm3 (p?=?0.01) and further increase with hydration to 6.7?±?2.1 cm3 and 6.3?±?1.9 cm3 (p?=?0.01). CMR venography on patients also demonstrated an increase in mean common femoral vein luminal area from 103?±?44 mm2 in supine position to 151?±?52 mm2 with prone positioning (p?<?0.001) as well as increases in common and external iliac vein volumes from 6.5?±?2.6 cm3 and 8.0?±?3.4 cm3 in the supine position to 7.5?±?2.5 cm3 and 9.3?±?3.6 cm3 with prone positioning (p?<?0.01).ConclusionsCommon femoral and common/external iliac vein size on CMR venography may be affected by position and hydration status. Routine clinical CMR venography of the pelvis could include prone positioning and avoiding dehydration to maximize pelvic vein distension.

Dataset Information

The use of brain functional magnetic resonance imaging to determine the mechanism of action of gabapentin in managing chronic pelvic pain in women: a pilot study.

Objective

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusions

Trial registration number

Publications

The use of brain functional magnetic resonance imaging to determine the mechanism of action of gabapentin in managing chronic pelvic pain in women: a pilot study.

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