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

Completed

• Conditions: Persistent Pain After Open Inguinal Herniotomy

• Registration Number: NCT01768130
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test- retest variability of thermal thresholds.	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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark