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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01020162
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Chronic Pelvic Pain Drug: Amitryptiline, gabapentin Procedure: Resection of the ilioinguinal nerve

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial
Study Start Date : September 1995
Primary Completion Date : December 2006
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Non-surgical
TENS, amitriptyline, gabapentin.
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:
  • Amitryptiline - Saroten
  • Gabapentin - Neurontin
Active Comparator: Surgical intervention
Resection of the ilioinguinal nerve
Procedure: Resection of the ilioinguinal nerve
In general anaesthesia the nerve was identified and resected as central as possible


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Drug abuse
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020162


Locations
Sweden
Dept Obstetrics&Gynecology/East Hospital
Gothenburg, Sweden, S-41685
Sponsors and Collaborators
Göteborg University
Investigators
Study Chair: Ian Milsom, MD,PhD Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
More Information

Responsible Party: Lennart Hahn, MD PHD, Dept of Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg
ClinicalTrials.gov Identifier: NCT01020162     History of Changes
Other Study ID Numbers: 429-05
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Göteborg University:
Chronic pelvic pain
ilioinguinal nerve entrapment
randomized study
Chronic pelvic pain in women

Additional relevant MeSH terms:
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Amitriptyline
Amitriptyline, perphenazine drug combination
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Analgesics, Non-Narcotic