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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768130
First Posted: January 15, 2013
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark
  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 Joakim Bischoff, 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)
  Eligibility

Information from the National Library of Medicine

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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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768130


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

Responsible Party: Joakim Bischoff, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01768130     History of Changes
Other Study ID Numbers: H-2-2011-023
First Submitted: January 7, 2013
First Posted: January 15, 2013
Last Update Posted: February 28, 2014
Last Verified: February 2014