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

NCT ID: NCT01020162

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-09-30

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Chronic Pelvic Pain

Keywords

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Chronic pelvic pain ilioinguinal nerve entrapment randomized study Chronic pelvic pain in women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-surgical

TENS, amitriptyline, gabapentin.

Group Type ACTIVE_COMPARATOR

Amitryptiline, gabapentin

Intervention Type DRUG

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.

Surgical intervention

Resection of the ilioinguinal nerve

Group Type ACTIVE_COMPARATOR

Resection of the ilioinguinal nerve

Intervention Type PROCEDURE

In general anaesthesia the nerve was identified and resected as central as possible

Interventions

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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.

Intervention Type DRUG

Resection of the ilioinguinal nerve

In general anaesthesia the nerve was identified and resected as central as possible

Intervention Type PROCEDURE

Other Intervention Names

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Amitryptiline - Saroten Gabapentin - Neurontin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Drug abuse
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Dept of Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg

Principal Investigators

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Ian Milsom, MD,PhD

Role: STUDY_CHAIR

Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden

Locations

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Dept Obstetrics&Gynecology/East Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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429-05

Identifier Type: -

Identifier Source: org_study_id