Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain

Chronic Pelvic Pain Clinical Trial

Official title:

Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020162
• Other study ID #: 429-05
• Status: Completed
• Phase: N/A
• First received: November 23, 2009
• Last updated: November 23, 2009
• Start date: September 1995
• Est. completion date: November 2007

Study information

• Verified date: November 2009
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment

Exclusion Criteria:

• Drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• 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.

Procedure:
• Resection of the ilioinguinal nerve
In general anaesthesia the nerve was identified and resected as central as possible

Locations

Country	Name	City	State
Sweden	Dept Obstetrics&Gynecology/East Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales.		At least one year after intervention,in some cases more then five years.	No