Variability in Thermal Thresholds in Patients With Persis... | NCT01768130

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

NCT01768130

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Persistent Pain After Open Inguinal Herniotomy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jan 7, 2013

First Submission Date that Met QC Criteria

Jan 11, 2013

First Posted Date

Jan 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with persistent pain after open inguinal herniotomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen	Ø	2100	Denmark