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

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ClinicalTrials.gov Identifier: NCT01768130
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark

Brief Summary:
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 or disease
Persistent Pain After Open Inguinal Herniotomy

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy
Study Start Date : April 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013



Primary Outcome Measures :
  1. 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.



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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

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

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