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

November 23, 2009
November 23, 2009
September 1995
December 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Pelvic Pain
  • 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
  • Procedure: Resection of the ilioinguinal nerve
    In general anaesthesia the nerve was identified and resected as central as possible
  • Active Comparator: Non-surgical
    TENS, amitriptyline, gabapentin.
    Intervention: Drug: Amitryptiline, gabapentin
  • Active Comparator: Surgical intervention
    Resection of the ilioinguinal nerve
    Intervention: Procedure: Resection of the ilioinguinal nerve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
November 2007
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Drug abuse
Female
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01020162
429-05
No
Lennart Hahn, MD PHD, Dept of Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg
Göteborg University
Not Provided
Study Chair: Ian Milsom, MD,PhD Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
Göteborg University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP