Dataset Information

GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol.

ABSTRACT:

Introduction

Chronic pelvic pain (CPP) affects >1 million UK women. Annual healthcare costs are estimated at >£150 million. Proven interventions for CPP are limited, and treatment is often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions, but there are insufficient data supporting value in CPP specifically. The mechanism by which gabapentin exerts its analgesic action is unknown. Given the prevalence and costs of CPP, the authors believe that a large, multicentre, placebo-controlled, double-blind randomised controlled trial to evaluate the efficacy of gabapentin in management of CPP is required. The focus of this study is a pilot to inform planning of a future randomised controlled trial.

Methods and analysis

The authors plan to perform a two-arm, parallel, randomised controlled pilot trial. The authors aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian (UK) and randomise them to gabapentin or placebo. Response to treatment will be monitored by questionnaire compared at 0, 3 and 6 months. The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness and acceptability to participants of the proposed methods of recruitment, randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin.

Ethics and dissemination

Ethical approval has been obtained from the Scotland A Research Ethics Committee (LREC 12/SS/0005). Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

ISRCTN70960777.

SUBMITTER: Horne AW

PROVIDER: S-EPMC3371581 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol.

Horne Andrew W AW Critchley Hilary O D HO Doust Ann A Fehr Daniel D Wilson John J Wu Olivia O Jack S S Porter Maureen M Lewis Steff S Bhattacharya Siladitya S

BMJ open 20120608 3

<h4>Introduction</h4>Chronic pelvic pain (CPP) affects >1 million UK women. Annual healthcare costs are estimated at >£150 million. Proven interventions for CPP are limited, and treatment is often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions, but there are insufficient data supporting value in CPP specifically. The mechanism by which gabapentin exerts its analgesic action is unknown. Given the prevalence and costs of CPP, ...[more]

PMID: 22685224

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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:BackgroundPersistent pelvic pain is pain sensed in or around the pelvis and is often associated with negative cognitive, behavioral, sexual, and emotional consequences. The lack of interprofessional persistent pelvic pain management programs that address the complex interplay of biopsychosocial factors result in lengthy wait times and negative health outcomes. Limited access to evidence informed self-management educational resources contributes to poor coping strategies. Evidence shows that self-management education and strategies support patients while they wait for care. However, very few studies explore the patient's lived experience of participating in an online educational program designed for persistent pelvic pain.ObjectivesThis study aims to understand the experience of women with persistent pelvic pain participating in an online, self-management education program ("Pelvic Pain Empowered Management" program) while awaiting care at an interprofessional pelvic pain clinic.DesignA descriptive qualitative approach was used to explore the experiences of women participating in an online educational program designed for cis women with persistent pelvic pain.MethodsWe conducted semi-structured interviews with 11 women, transcribed the data verbatim using NVivo software (NVivo 12, QSR International Pty Ltd.), and analyzed inductively using previously established methods.ResultsWe identified four main themes relevant to women's experiences of the program: (1) the program shaped expectations around upcoming pelvic pain appointments, (2) the program content is relevant and resonates with people with lived experience of persistent pelvic pain, (3) the program enhanced understanding of persistent pelvic pain, and (4) the program empowered people with skills and strategies to better manage their persistent pelvic pain.ConclusionOur findings highlight how self-directed online patient education can be leveraged while persistent pelvic pain patients wait for care to support them in setting expectations around care and in engaging in pain self-management.

Project description:BackgroundEndometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial peritoneal endometriosis (SPE). Endometriosis is diagnosed by laparoscopy and, if SPE is found, gynaecologists usually remove it surgically. However, many women get limited pain relief from surgical removal of SPE. We plan to undertake a future large trial where women who have only SPE found at initial laparoscopy are randomly allocated to have surgical removal (excision or ablation) of SPE, or not. Ultimately, we want to determine whether surgical removal improves overall symptoms and quality of life, or whether surgery is of no benefit, exacerbates symptoms, or even causes harm. The primary objective of this feasibility study is to determine what proportion of women with suspected SPE undergoing diagnostic laparoscopy will agree to randomisation. The secondary objectives are to determine if there are differences in key prognostic parameters between eligible women that agree to be randomised and those that decline; how many women having laparoscopy for investigation of chronic pelvic pain are eligible for the trial; the range of treatment effects and variability in outcomes and the most acceptable methods of recruitment, randomisation and assessment tools.MethodsWe will recruit up to 90 women with suspected SPE undergoing diagnostic laparoscopy over a 9-month recruitment period in four Scottish hospitals and randomise them 1:1 to either diagnostic laparoscopy alone (with a sham port to achieve blinding of the allocation) or surgical removal of endometriosis. Baseline characteristics, e.g. age, index of social deprivation, ethnicity, and intensity/duration of pain will be collected. Participants will be followed up by online questionnaires assessing pain, physical and emotional function at baseline, 3 months, 6 months and 12 months.DiscussionRecruitment to a randomised controlled trial to assess the effectiveness of surgery for endometriosis may be challenging because of preconceived ideas about treatment success amongst patients and clinicians. We have designed this study to assess feasibility of recruitment and to inform the design of our future definitive trial.Trial registrationClincicalTrials.gov, NCT04081532 STATUS: Recruiting.

Dataset Information

GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol.

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