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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768130
Other study ID # H-2-2011-023
Secondary ID
Status Completed
Phase N/A
First received January 7, 2013
Last updated February 27, 2014
Start date April 2011
Est. completion date October 2013

Study information

Verified date February 2014
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: ethics committee of the Capital Region of Denmark
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Persistent Pain After Open Inguinal Herniotomy

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test- retest variability of thermal thresholds. Analysis of agreement (Bland-Altman) and reliability (intraclass correlation coefficients) of thermal threshold test- retest data assessed at baseline and after 4-6 weeks. At baseline and retest 4-6 weeks later No