Neurophysiological Characterization of Postherniotomy Pain

April 4, 2014 updated by: Eske Kvanner Aasvang, Rigshospitalet, Denmark

Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients

Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Danish Pain Research Centre
      • Copenhagen, Denmark, 2100
        • Section for Surgical Pathophysiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

persistent posthenriotomy patients

Description

Inclusion Criteria:

  • Male patients >18 yrs
  • Inguinal herniotomy >1 yr previously
  • No sign of hernia recurrence
  • Unilateral chronic groin pain lasting more than 3 months
  • Moderate/severe pain related impairment of everyday activities.

Exclusion Criteria:

  • Other causes of persistent pain in groin region (hip, other surgical procedures)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
pain-free control
Pain-free controls from previous prospective study (KF 01294867), operated >2 years previously
Pain Patients
Patients with persistent postherniotomy pain lasting >1 year and pain related impaired daily function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensory function
Time Frame: actual
actual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Eske K Aasvang, M.D., Rigshospitalet, Copenhagen University, Denmark
  • Principal Investigator: Henrik Kehlet, M.D., Ph. D., Rigshospitalet, Copenhagen University, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01267755

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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