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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01768130
First received: January 7, 2013
Last updated: February 27, 2014
Last verified: February 2014
  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.


Enrollment: 21
Study Start Date: April 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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
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: NCT01768130

Locations
Denmark
Rigshospitalet
Copenhagen, Ø, Denmark, 2100
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: February 27, 2014
Health Authority: Denmark: ethics committee of the Capital Region of Denmark

ClinicalTrials.gov processed this record on November 25, 2014