Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Overview[ - collapse ][ - ]
Purpose | 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. |
---|---|
Condition | Chronic Pelvic Pain |
Intervention | Drug: Amitryptiline, gabapentin Procedure: Resection of the ilioinguinal nerve |
Phase | N/A |
Sponsor | Göteborg University |
Responsible Party | Göteborg University |
ClinicalTrials.gov Identifier | NCT01020162 |
First Received | November 23, 2009 |
Last Updated | November 23, 2009 |
Last verified | November 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | November 23, 2009 |
---|---|
Last Updated Date | November 23, 2009 |
Start Date | September 1995 |
Estimated Primary Completion Date | November 2007 |
Current Primary Outcome Measures | 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.] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
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 |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Chronic Pelvic Pain |
Intervention | Drug: Amitryptiline, gabapentin 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. Other Names:
In general anaesthesia the nerve was identified and resected as central as possible |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 19 |
Estimated Completion Date | November 2007 |
Estimated Primary Completion Date | December 2006 |
Eligibility Criteria | Inclusion Criteria: - Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment Exclusion Criteria: - Drug abuse |
Gender | Female |
Ages | 15 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Sweden |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01020162 |
---|---|
Other Study ID Numbers | 429-05 |
Has Data Monitoring Committee | No |
Information Provided By | Göteborg University |
Study Sponsor | Göteborg University |
Collaborators | Not Provided |
Investigators | Study Chair: Ian Milsom, MD,PhD Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden |
Verification Date | November 2009 |
Locations[ + expand ][ + ]
Dept Obstetrics&Gynecology/East Hospital | Gothenburg, Sweden, S-41685 |
---|