Clinical Trial: Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method
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 Summary:
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).
Sponsor: Rigshospitalet, Denmark
Current Primary Outcome: comparison of secondary hyperalgesia areas assessed by the polyamide filaments [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Rigshospitalet, Denmark
Dates:
Date Received: February 7, 2014
Date Started: August 2013
Date Completion:
Last Updated: November 6, 2014
Last Verified: November 2014
