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.
ConditionChronic Pelvic Pain
InterventionDrug: Amitryptiline, gabapentin
Procedure: Resection of the ilioinguinal nerve
PhaseN/A
SponsorGöteborg University
Responsible PartyGöteborg University
ClinicalTrials.gov IdentifierNCT01020162
First ReceivedNovember 23, 2009
Last UpdatedNovember 23, 2009
Last verifiedNovember 2009

Tracking Information[ + expand ][ + ]

First Received DateNovember 23, 2009
Last Updated DateNovember 23, 2009
Start DateSeptember 1995
Estimated Primary Completion DateNovember 2007
Current Primary Outcome MeasuresImprovements 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 MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleTreatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Official TitleTreatment 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 DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionChronic Pelvic Pain
InterventionDrug: 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:
  • Amitryptiline - Saroten
  • Gabapentin - Neurontin
Procedure: Resection of the ilioinguinal nerve
In general anaesthesia the nerve was identified and resected as central as possible
Study Arm (s)
  • Active Comparator: Non-surgical
    TENS, amitriptyline, gabapentin.
  • Active Comparator: Surgical intervention
    Resection of the ilioinguinal nerve

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment19
Estimated Completion DateNovember 2007
Estimated Primary Completion DateDecember 2006
Eligibility Criteria
Inclusion Criteria:

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

Exclusion Criteria:

- Drug abuse
GenderFemale
Ages15 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesSweden

Administrative Information[ + expand ][ + ]

NCT Number NCT01020162
Other Study ID Numbers429-05
Has Data Monitoring CommitteeNo
Information Provided ByGöteborg University
Study SponsorGöteborg University
CollaboratorsNot Provided
Investigators Study Chair: Ian Milsom, MD,PhD Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
Verification DateNovember 2009

Locations[ + expand ][ + ]

Dept Obstetrics&Gynecology/East Hospital
Gothenburg, Sweden, S-41685