The University of Southampton
University of Southampton Institutional Repository

GaPP2: A multi-centre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women: study protocol

GaPP2: A multi-centre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women: study protocol
GaPP2: A multi-centre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women: study protocol
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 (GaPP1) and here describe the protocol for the definitive multicentre trial to assess the efficacy of gabapentin in the management of CPP in women (GaPP2).

Methods and analysis:
We plan to perform a double blind placebo controlled randomised multi-centre clinical trial, recruiting 300 women with CPP from more than 8 NHS hospitals within the UK. After randomisation, women will titrate their medication (gabapentin or placebo) over a 4-week period to a maximum of 2700mg 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 co-primary 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
2044-6055
1-8
Vincent, Katy
6e4a96d4-fddd-42a4-8ff5-14bb30671184
Baranowski, Andrew
1dcc09ac-0bc9-4a34-a1a4-5b643025fe92
Bhattacharya, Siladitya
4c912cdf-d691-49e0-bf8c-cdf0e40fc275
Birch, Judy
01c50a0f-ab56-4fd6-a148-8e5e75d456d5
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Cregg, Roman
26f58098-7483-416a-b048-070f9c3434f8
Daniels, Jane
2f3a7a69-7c19-47e8-b1a7-ebdd74e313d9
Hewitt, Catherine A.
c89885dc-5d2b-4fde-ba1b-4fc819fe5b36
Macfarlane, Gary J.
e17bbdb7-9d82-42ac-8a0a-09bf10885e3c
Middleton, Lee
5fb39a8c-1d0e-4aaf-b93d-077900d7b56d
Szubert, Wojciech
f675e41e-278b-42c0-a8c3-d16dac36746c
Tracey, Irene
f873de18-d525-4de6-aafa-3dfaa5f69d90
de Williams, Amanda C.
1928e7b8-c6d1-49e3-8c94-19242b0a8635
Horne, Andrew W.
82f2bcc1-6e8d-454c-83d2-744e6c9bd831
Vincent, Katy
6e4a96d4-fddd-42a4-8ff5-14bb30671184
Baranowski, Andrew
1dcc09ac-0bc9-4a34-a1a4-5b643025fe92
Bhattacharya, Siladitya
4c912cdf-d691-49e0-bf8c-cdf0e40fc275
Birch, Judy
01c50a0f-ab56-4fd6-a148-8e5e75d456d5
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Cregg, Roman
26f58098-7483-416a-b048-070f9c3434f8
Daniels, Jane
2f3a7a69-7c19-47e8-b1a7-ebdd74e313d9
Hewitt, Catherine A.
c89885dc-5d2b-4fde-ba1b-4fc819fe5b36
Macfarlane, Gary J.
e17bbdb7-9d82-42ac-8a0a-09bf10885e3c
Middleton, Lee
5fb39a8c-1d0e-4aaf-b93d-077900d7b56d
Szubert, Wojciech
f675e41e-278b-42c0-a8c3-d16dac36746c
Tracey, Irene
f873de18-d525-4de6-aafa-3dfaa5f69d90
de Williams, Amanda C.
1928e7b8-c6d1-49e3-8c94-19242b0a8635
Horne, Andrew W.
82f2bcc1-6e8d-454c-83d2-744e6c9bd831

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, de Williams, Amanda C. and Horne, Andrew W. (2018) GaPP2: A multi-centre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women: study protocol. BMJ Open, 8 (1), 1-8. (doi:10.1136/bmjopen-2016-014924).

Record type: Article

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 (GaPP1) and here describe the protocol for the definitive multicentre trial to assess the efficacy of gabapentin in the management of CPP in women (GaPP2).

Methods and analysis:
We plan to perform a double blind placebo controlled randomised multi-centre clinical trial, recruiting 300 women with CPP from more than 8 NHS hospitals within the UK. After randomisation, women will titrate their medication (gabapentin or placebo) over a 4-week period to a maximum of 2700mg 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 co-primary 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

Text
GaPP2_protocol_200917 CLEAN - Accepted Manuscript
Download (69kB)
Text
e014924.full - Version of Record
Available under License Creative Commons Attribution.
Download (938kB)

More information

Accepted/In Press date: 2 October 2017
e-pub ahead of print date: 31 January 2018

Identifiers

Local EPrints ID: 414912
URI: https://eprints.soton.ac.uk/id/eprint/414912
ISSN: 2044-6055
PURE UUID: fa8341e0-5391-4edd-9c4f-03abe38d3f9e
ORCID for Ying Cheong: ORCID iD orcid.org/0000-0001-7687-4597

Catalogue record

Date deposited: 16 Oct 2017 16:30
Last modified: 20 Jul 2019 04:48

Export record

Altmetrics

Contributors

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

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×