| Source of record | UK Trials |
| ISRCTN | ISRCTN41196151 |
| Date ISRCTN assigned | 08/10/2002 |
| Local reference number(s) | N/A |
| 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 |
| Disease/condition/study domain | Chronic pelvic pain in women |
| 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) |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/09/2004 |
| Anticipated end date | 01/09/2005 |
| Status of trial | Completed |
| 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 |
| Publications | Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14662012 |
| Sources of funding | Wellbeing (UK) (ref: CF/371) |
| Sponsor name | University of Birmingham (UK) |
| Sponsor details | Edgbaston
Birmingham
United Kingdom
B15 2TT |
| Sponsor telephone | +44 (0)121 414 3344 |
| Sponsor fax | +44 (0)121 414 3971 |
| Sponsor email | postmaster@bham.ac.uk |
| Sponsor website | http://www.bham.ac.uk/ |
| Contact name | Mr Khalid Khan |
| Contact details | Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
Birmingham
United Kingdom
B15 2TG |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN41196151 |
| Date last extracted from ISRCTN register | 17/04/2008 |
