Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method

Completed

• Conditions: Measurements of Areas of Secondary Hyperalgesia

• Registration Number: NCT02286037
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Assessments of mechanical skin sensitivity include psychophysical responses to stimulation with calibrated polyamide monofilaments.

One of the applications of polyamide monofilaments are the assessments of magnitude of secondary hyperalgesia areas (SHAs), i.e. areas in normal skin near an injury with increased mechanical sensitivity.

The objective of the study is to investigate the hypothesis, based on previous studies, that a light tactile stimulus delineates a larger SHA than stimulation with a more rigid monofilament.

Twenty-three healthy participants were included in this randomized, two-observer, test-retest study.

A highly significant positive correlation between the bending force of the polyamide filaments and the magnitude of SHA was demonstrated. The "weighted-pin" instrument showed significantly and consistently larger areas than the polyamide monofilaments.

The hypothesis was rejected: a light tactile stimulus did not delineate a larger secondary hyperalgesia area than stimulation with a more rigid monofilament. The "weighted-pin" instrument seems an alternative to the conventional polyamide monofilaments.

Detailed Description

Introduction Assessments of mechanical skin sensitivity include psychophysical responses to stimulation with calibrated polyamide monofilaments. Although the theoretical background and the application of monofilaments are straightforward, inconsistencies of the method have been reported in the literature. One of the applications of polyamide monofilaments are the assessments of magnitude of secondary hyperalgesia areas (SHAs), i.e. areas in normal skin near an injury with increased mechanical sensitivity. Secondary hyperalgesia is a measure of central sensitization and reflects the effect of an injury on the central nervous system. The objective of the study is to investigate the hypothesis, based on previous studies, that a light tactile stimulus delineates a larger SHA than stimulation with a more rigid monofilament.

Method Twenty-three healthy participants were included in this randomized, two-observer, test-retest study. The volunteers were blinded to the test-results. The design was adjusted to examine intra-/inter-observer and intra-/inter-day variability in SHAs after a first degree burn injury was induced by a contact thermode (47ºC, 7 minutes, thermode area 12.5 cm2) on the lower leg. The SHAs were assessed 45 to 75 min (15 min for each observer) after the burn injury and delineated by 3 different polyamide monofilaments (50, 299, 986 mN) and a "weighted-pin" instrument (512 mN). The testing order of the monofilaments was randomized, and the observers were blinded to the study results of each other. The examination order of the observers on Day 1 was reversed on Day 2 (\> 6 weeks later).

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-02-07
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-06
• Last Update Submitted: 2014-11-06
• Study First Posted: 2014-11-07
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of secondary hyperalgesia areas assessed by the polyamide filaments	6 weeks