GaPP2, a multicentre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women

study protocol

Katy Vincent, Andrew Baranowski, Siladitya Bhattacharya, Judy Birch, Ying Cheong, Roman Cregg, Jane Daniels, Catherine A Hewitt, Gary J Macfarlane, Lee Middleton, Wojciech Szubert, Irene Tracey, Amanda C de C Williams, Andrew W Horne

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Abstract

INTRODUCTION: Chronic pelvic pain (CPP) affects more than 1 million UK women with associated healthcare costs of £158 million annually. Current evidence supporting interventions when no underlying pathology is identified is very limited and treatment is frequently inadequate. Gabapentin (a GABA analogue) is efficacious and often well tolerated in other chronic pain conditions. We have completed a successful pilot randomised controlled trial Gabapentin for Pelvic Pain 1 (GaPP1) and here describe the protocol for our definitive multicentre trial to assess the efficacy of gabapentin in the management of CPP in women Gabapentin for Pelvic Pain 2 (GaPP2).

METHODS AND ANALYSIS: We plan to perform a double-blind placebo-controlled randomised multicentre clinical trial, recruiting 300 women with CPP from up to 40 National Health Service hospitals within the UK. After randomisation, women will titrate their medication (gabapentin or placebo) over a 4-week period to a maximum of 2700 mg or placebo equivalent and will then maintain a stable dose for a 12-week period. Response to treatment will be monitored with validated questionnaires and coprimary outcome measures of average and worst pain scores will be employed. The primary objective is to test the hypothesis that treatment with gabapentin has the potential to provide an effective oral treatment to alleviate pain in women with CPP in the absence of any obvious pelvic pathology.

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Coventry and Warwick Research Ethics Committee (REC 15/WM/0036). Data will be presented at international conferences and published in peer-reviewed journals. We will make the information obtained from the study available to the public through national bodies and charities.

TRIAL REGISTRATION NUMBER: ISRCTN77451762; Pre-results.

Original languageEnglish
Article numbere014924
JournalBMJ Open
Volume8
Issue number1
DOIs
Publication statusPublished - 31 Jan 2018

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Pelvic Pain
Chronic Pain
Randomized Controlled Trials
Placebos
Multicenter Studies
Pathology
Charities
Pain
Research Ethics Committees
National Health Programs
Therapeutics
Random Allocation
Health Care Costs
gamma-Aminobutyric Acid
gabapentin
Outcome Assessment (Health Care)

Keywords

  • Journal Article
  • Research Support, Non-U.S. Gov't

Cite this

GaPP2, a multicentre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women : study protocol. / Vincent, Katy; Baranowski, Andrew; Bhattacharya, Siladitya; Birch, Judy; Cheong, Ying; Cregg, Roman; Daniels, Jane; Hewitt, Catherine A; Macfarlane, Gary J; Middleton, Lee; Szubert, Wojciech; Tracey, Irene; Williams, Amanda C de C; Horne, Andrew W.

In: BMJ Open, Vol. 8, No. 1, e014924, 31.01.2018.

Research output: Contribution to journalArticle

Vincent, K, Baranowski, A, Bhattacharya, S, Birch, J, Cheong, Y, Cregg, R, Daniels, J, Hewitt, CA, Macfarlane, GJ, Middleton, L, Szubert, W, Tracey, I, Williams, ACDC & Horne, AW 2018, 'GaPP2, a multicentre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women: study protocol', BMJ Open, vol. 8, no. 1, e014924. https://doi.org/10.1136/bmjopen-2016-014924
Vincent, Katy ; Baranowski, Andrew ; Bhattacharya, Siladitya ; Birch, Judy ; Cheong, Ying ; Cregg, Roman ; Daniels, Jane ; Hewitt, Catherine A ; Macfarlane, Gary J ; Middleton, Lee ; Szubert, Wojciech ; Tracey, Irene ; Williams, Amanda C de C ; Horne, Andrew W. / GaPP2, a multicentre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women : study protocol. In: BMJ Open. 2018 ; Vol. 8, No. 1.
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AU - Vincent, Katy

AU - Baranowski, Andrew

AU - Bhattacharya, Siladitya

AU - Birch, Judy

AU - Cheong, Ying

AU - Cregg, Roman

AU - Daniels, Jane

AU - Hewitt, Catherine A

AU - Macfarlane, Gary J

AU - Middleton, Lee

AU - Szubert, Wojciech

AU - Tracey, Irene

AU - Williams, Amanda C de C

AU - Horne, Andrew W

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N2 - INTRODUCTION: Chronic pelvic pain (CPP) affects more than 1 million UK women with associated healthcare costs of £158 million annually. Current evidence supporting interventions when no underlying pathology is identified is very limited and treatment is frequently inadequate. Gabapentin (a GABA analogue) is efficacious and often well tolerated in other chronic pain conditions. We have completed a successful pilot randomised controlled trial Gabapentin for Pelvic Pain 1 (GaPP1) and here describe the protocol for our definitive multicentre trial to assess the efficacy of gabapentin in the management of CPP in women Gabapentin for Pelvic Pain 2 (GaPP2).METHODS AND ANALYSIS: We plan to perform a double-blind placebo-controlled randomised multicentre clinical trial, recruiting 300 women with CPP from up to 40 National Health Service hospitals within the UK. After randomisation, women will titrate their medication (gabapentin or placebo) over a 4-week period to a maximum of 2700 mg or placebo equivalent and will then maintain a stable dose for a 12-week period. Response to treatment will be monitored with validated questionnaires and coprimary outcome measures of average and worst pain scores will be employed. The primary objective is to test the hypothesis that treatment with gabapentin has the potential to provide an effective oral treatment to alleviate pain in women with CPP in the absence of any obvious pelvic pathology.ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Coventry and Warwick Research Ethics Committee (REC 15/WM/0036). Data will be presented at international conferences and published in peer-reviewed journals. We will make the information obtained from the study available to the public through national bodies and charities.TRIAL REGISTRATION NUMBER: ISRCTN77451762; Pre-results.

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JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

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