Back to resultsTreatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Primary Purpose
Chronic Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Amitryptiline, gabapentin
Resection of the ilioinguinal nerve
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring Chronic pelvic pain, ilioinguinal nerve entrapment, randomized study, Chronic pelvic pain in women
Eligibility Criteria
Inclusion Criteria:
- Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment
Exclusion Criteria:
- Drug abuse
Sites / Locations
- Dept Obstetrics&Gynecology/East Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Non-surgical
Surgical intervention
Arm Description
TENS, amitriptyline, gabapentin.
Resection of the ilioinguinal nerve
Outcomes
Primary Outcome Measures
Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales.
Secondary Outcome Measures
Full Information
NCT ID
NCT01020162
First Posted
November 23, 2009
Last Updated
November 23, 2009
Sponsor
Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT01020162
Brief Title
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Official Title
Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Göteborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain
Keywords
Chronic pelvic pain, ilioinguinal nerve entrapment, randomized study, Chronic pelvic pain in women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-surgical
Arm Type
Active Comparator
Arm Description
TENS, amitriptyline, gabapentin.
Arm Title
Surgical intervention
Arm Type
Active Comparator
Arm Description
Resection of the ilioinguinal nerve
Intervention Type
Drug
Intervention Name(s)
Amitryptiline, gabapentin
Other Intervention Name(s)
Amitryptiline - Saroten, Gabapentin - Neurontin
Intervention Description
For amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid.
Intervention Type
Procedure
Intervention Name(s)
Resection of the ilioinguinal nerve
Intervention Description
In general anaesthesia the nerve was identified and resected as central as possible
Primary Outcome Measure Information:
Title
Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales.
Time Frame
At least one year after intervention,in some cases more then five years.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment
Exclusion Criteria:
Drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Milsom, MD,PhD
Organizational Affiliation
Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Dept Obstetrics&Gynecology/East Hospital
City
Gothenburg
ZIP/Postal Code
S-41685
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
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