Inter-observer and Intra-observer Variability of the Wrinkle Test

Inter-observer and Intra-observer Variability of the Wrinkle Test and the Optimum Time Need for the Test. Pilot Study

Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic innervation. It is abolished by lesions affecting both central and peripheral sympathetic pathways. It affords a simple and reliable clinical test of sympathetic function.

Study Overview

• Status: Unknown
• Conditions: Wrinkle Test
• Intervention / Treatment: Diagnostic test: wrinkle test

Detailed Description

Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon, whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients after suture of full cut of digital nerve

Description

Inclusion Criteria:

• patients after suture of full cut of digital nerve

Exclusion Criteria:

• other nerve injury

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
finger after digital nerve cut	Diagnostic test: wrinkle test; soaking in 40 deg water for 40 min. every 10 min the hand will be photo
healthy finger	Diagnostic test: wrinkle test; soaking in 40 deg water for 40 min. every 10 min the hand will be photo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wrinkle test	wrinkle of the skin in the finger compaared to the finger witout digital nerve injury	40 min

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 15, 2019
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (ACTUAL): January 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 134-18-EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No