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A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain
ISRCTN ISRCTN41196151
DOI 10.1186/ISRCTN41196151
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain
Scientific title
Acronym LUNA
Serial number at source N/A
Study hypothesis 1. To test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (American Fertility Society [AFS] score less than or equal to 5) LUNA alleviates pain and improves life quality at 12 months (principal objective)
2. To test the hypothesis that response to LUNA differs according to the site and cause of the pain by two secondary analyses:
2.1. Women with central pain
2.2. Women with no visible pathology
3. To explore the variation in LUNA's effectiveness and side effects at different periods of follow-up (3 and 6 months and 1, 2, 3, 5 and 10 years)
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic pelvic pain in women
Participants - inclusion criteria New patients presenting to the gynaecology outpatient clinic with pelvic pain (cyclical or non-cyclical) and/or dyspareunia, and requiring diagnostic laparoscopy for evaluation of these conditions, will be invited to participate.

Inclusion criteria:
1. Pelvic pain of longer than 6 month duration
2. Pain located within the true pelvis or between and below the anterior iliac crests
3. Associated functional disability
4. Lack of response to medical treatment
5. Diagnostic laparoscopy planned
Participants - exclusion criteria Does not match inclusion criteria
Anticipated start date 01/09/2004
Anticipated end date 01/09/2005
Status of trial Completed
Patient information material
Target number of participants 420
Interventions 1. Diagnostic laparoscopy plus uterosacral nerve ablation (experimental group)
2. Laparoscopy without pelvic denervation (control group)
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Wellbeing (UK) (ref: CF/371)
Trial website
Publications 1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14662012
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19724042
Contact name Mr  Khalid  Khan
  Address Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TG
  Country United Kingdom
Sponsor University of Birmingham (UK)
  Address Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TT
  Country United Kingdom
  Tel +44 (0)121 414 3344
  Fax +44 (0)121 414 3971
  Email postmaster@bham.ac.uk
  Sponsor website: http://www.bham.ac.uk/
Date applied 08/10/2002
Last edited 03/09/2009
Date ISRCTN assigned 08/10/2002
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