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Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy

This study is currently recruiting participants.
Verified January 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01768130
First received: January 7, 2013
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. In this area and in a contralateral area as a control, 5 sites were outlined, including the point of maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were repeated after a 4-6 weeks interval.


Condition
Persistent Pain After Open Inguinal Herniotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Test- retest variability of thermal thresholds. [ Time Frame: At baseline and retest 4-6 weeks later ] [ Designated as safety issue: No ]
    Analysis of agreement (Bland-Altman) and reliability (intraclass correlation coefficients) of thermal threshold test- retest data assessed at baseline and after 4-6 weeks.


Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with persistent pain after open inguinal herniotomy

Criteria

Inclusion Criteria:

  • Patients with persistent pain after open inguinal herniotomy
  • Age > 18 years

Exclusion Criteria:

  • Cognitive impairment
  • Drug or alcohol abuse
  • Bilateral inguinal hernia operation
  • Nerve injury from other causes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768130

Contacts
Contact: Joakim Bischoff, MD 35457612

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Ø, Denmark, 2100
Principal Investigator: Joakim Bischoff, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Joakim Bischoff, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01768130     History of Changes
Other Study ID Numbers: H-2-2011-023
Study First Received: January 7, 2013
Last Updated: January 11, 2013
Health Authority: Denmark: ethics committee of the Capital Region of Denmark

ClinicalTrials.gov processed this record on May 23, 2013