Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LUNA
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)
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic pelvic pain in women
Intervention
1. Diagnostic laparoscopy plus uterosacral nerve ablation (experimental group)
2. Laparoscopy without pelvic denervation (control group)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2004
Overall trial end date
01/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
420
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/2004
Recruitment end date
01/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Department of Obstetrics and Gynaecology
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3344
postmaster@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellbeing (UK) (ref: CF/371)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14662012
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19724042
Publication citations
-
Protocol
A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151]., BMC Womens Health, 2003, 3, 1, 6, doi: 10.1186/1472-6874-3-6.
-
Results
Daniels J, Gray R, Hills RK, Latthe P, Buckley L, Gupta J, Selman T, Adey E, Xiong T, Champaneria R, Lilford R, Khan KS, , Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain: a randomized controlled trial., JAMA, 2009, 302, 9, 955-961, doi: 10.1001/jama.2009.1268.