The effectiveness of gabapentin in the treatment of chronic pelvic pain in wome

Not Applicable

Completed

• Conditions: Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: General Gynaecology; Signs and Symptoms; Chronic pelvic pain

• Registration Number: ISRCTN77451762
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29391360 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32979978/ results (added 30/09/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33226738/ (added 30/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Study Completion: 2019-02-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 306

Inclusion Criteria

1. Women aged between 18-50 years
2. Chronic pelvic pain (non-cyclical with or without dysmenorrhoea or dyspareunia) of >3 months duration
3. Pain located within the true pelvis or between and below anterior iliac crests
4. No obvious pelvic pathology at laparoscopy (laparoscopy must have taken place at least 2 weeks ago, but no more than 36 months prior to screening)
5. Using or willing to use effective contraception if necessary to avoid pregnancy
6. Able to give informed consent
7. For both the worst and average pre-randomisation Numerical Rating Scale (NRS) questions, at least three of the four weekly scores returned to the trials office. At least two of the worst pain scores should be =4

Exclusion Criteria

1. Known pelvic pathology: o Endometriosis (macroscopic lesions) o complex or >5cm ovarian cyst o fibroid >3cm o dense adhesions
2. Current malignancy under treatment
3. Current use of gabapentin/pregabalin
4. Taking GnRH agonists and unable/unwilling to stop
5. Surgery planned in the next 6 months
6. History of significant renal impairment
7. Previous reaction to gabapentin
8. Breast feeding
9. Pregnancy
10. Planned pregnancy in next 6 months
11. Pain suspected to be of gastrointestinal origin (positive Rome III Diagnostic Criteria)
12. Prohibited medications (see SmPC – Appendix 2))
13. Metal implant/pacemaker/claustrophobia (fMRI subgroup only)
14. Co-enrolment in another CTIMP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic pain is measured using a numerical rating scale (NRS) at baseline and 13-16 weeks post-randomisation

Secondary Outcome Measures

Name	Time	Method
Physical/emotional functioning is assessed using questionnaires at baseline and week 16