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

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01020162
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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 Intervention
Chronic Pelvic Pain
Drug: Amitryptiline, gabapentin
Procedure: Resection of the ilioinguinal nerve

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Göteborg University:

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 ]

Enrollment: 19
Study Start Date: September 1995
Study Completion Date: November 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 23, 2009
Last Updated: November 23, 2009
Health Authority: Sweden: The National Board of Health and Welfare

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
Signs and Symptoms
Amitriptyline
Amitriptyline, perphenazine drug combination
Gabapentin
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antimanic Agents
Antiparkinson Agents
Antipsychotic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014