GaPP

A Pilot Randomised Controlled Trial of the Efficacy of Gabapentin for the Management of Chronic Pelvic Pain in Women

A. W. Horne, S. Lewis, O. Wu, S. Jack, H. Critchley, D. Cranley, S Bhattacharya

Research output: Contribution to journalAbstract

1 Citation (Scopus)

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.
Original languageEnglish
Pages (from-to)206A
Number of pages1
JournalReproductive Sciences
Volume22
Issue number1 Suppl.
DOIs
Publication statusPublished - Mar 2015

Cite this

GaPP : A Pilot Randomised Controlled Trial of the Efficacy of Gabapentin for the Management of Chronic Pelvic Pain in Women. / Horne, A. W.; Lewis, S.; Wu, O.; Jack, S.; Critchley, H.; Cranley, D.; Bhattacharya, S.

In: Reproductive Sciences, Vol. 22, No. 1 Suppl., 03.2015, p. 206A.

Research output: Contribution to journalAbstract

Horne, A. W. ; Lewis, S. ; Wu, O. ; Jack, S. ; Critchley, H. ; Cranley, D. ; Bhattacharya, S. / GaPP : A Pilot Randomised Controlled Trial of the Efficacy of Gabapentin for the Management of Chronic Pelvic Pain in Women. In: Reproductive Sciences. 2015 ; Vol. 22, No. 1 Suppl. pp. 206A.
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title = "GaPP: A Pilot Randomised Controlled Trial of the Efficacy of Gabapentin for the Management of Chronic Pelvic Pain in Women",
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.",
author = "Horne, {A. W.} and S. Lewis and O. Wu and S. Jack and H. Critchley and D. Cranley and S Bhattacharya",
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T1 - GaPP

T2 - A Pilot Randomised Controlled Trial of the Efficacy of Gabapentin for the Management of Chronic Pelvic Pain in Women

AU - Horne, A. W.

AU - Lewis, S.

AU - Wu, O.

AU - Jack, S.

AU - Critchley, H.

AU - Cranley, D.

AU - Bhattacharya, S

N1 - This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. Funding: This work is supported by a grant from the Chief Scientist's Office Scotland (CZH/4/688). AH is funded by an MRC Clinician Scientist Fellowship (G0802808). The funders and study sponsor will have no role in the study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.

PY - 2015/3

Y1 - 2015/3

N2 - 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.

AB - 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.

U2 - 10.1177/1933719115579631

DO - 10.1177/1933719115579631

M3 - Abstract

VL - 22

SP - 206A

JO - Reproductive Sciences

JF - Reproductive Sciences

SN - 1933-7191

IS - 1 Suppl.

ER -