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

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

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 ]
    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)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with persistent pain after open inguinal herniotomy

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
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Please refer to this study by its identifier: NCT01768130

Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Responsible Party: Joakim Bischoff, MD, Rigshospitalet, Denmark Identifier: NCT01768130     History of Changes
Other Study ID Numbers: H-2-2011-023
Study First Received: January 7, 2013
Last Updated: February 27, 2014 processed this record on April 28, 2017