Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method
Primary Purpose
Measurements of Areas of Secondary Hyperalgesia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Measurements of Areas of Secondary Hyperalgesia focused on measuring Secondary Hyperalgesia, Method, Pin-prick, Monofilament
Eligibility Criteria
Inclusion criteria:
- Healthy
- Age ≥18 years and ≤ 35 years
- Written informed consent
- Urine sample without any trace of opioids (morphine, methadone, buprenorphin)
- Body Mass Index: 18 < BMI < 32 kg/cm2
Exclusion criteria:
- Inadequate psychomotor ability to cooperate
- Inability to understand Danish or English
- Participated in another study in the preceding 60 days
- Known neurological disease
- Use of psychoactive drugs (benzodiazepines, SSRI, TCA, SNRI)
- Alcohol or drug abuse
- Chronic pain
- Use of pain medication on a regular basis
- Skin lesions in the examination area
- Use of prescription medicine 1 week before examination
- Use of over-the-counter (OTC) drugs 48 hours before examination
- Smoker
Sites / Locations
Outcomes
Primary Outcome Measures
comparison of secondary hyperalgesia areas assessed by the polyamide filaments
Secondary Outcome Measures
Full Information
NCT ID
NCT02286037
First Posted
February 7, 2014
Last Updated
November 6, 2014
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02286037
Brief Title
Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method
Official Title
Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method
Study Type
Observational
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measurements of Areas of Secondary Hyperalgesia
Keywords
Secondary Hyperalgesia, Method, Pin-prick, Monofilament
7. Study Design
Enrollment
23 (Actual)
Primary Outcome Measure Information:
Title
comparison of secondary hyperalgesia areas assessed by the polyamide filaments
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy
Age ≥18 years and ≤ 35 years
Written informed consent
Urine sample without any trace of opioids (morphine, methadone, buprenorphin)
Body Mass Index: 18 < BMI < 32 kg/cm2
Exclusion criteria:
Inadequate psychomotor ability to cooperate
Inability to understand Danish or English
Participated in another study in the preceding 60 days
Known neurological disease
Use of psychoactive drugs (benzodiazepines, SSRI, TCA, SNRI)
Alcohol or drug abuse
Chronic pain
Use of pain medication on a regular basis
Skin lesions in the examination area
Use of prescription medicine 1 week before examination
Use of over-the-counter (OTC) drugs 48 hours before examination
Smoker
Study Population Description
Healthy participants
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas K Ringsted, Nurse,cand.
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Delineating Areas of Secondary Hyperalgesia: Influence of the Assessment Method
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