search
Back to results

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
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 7, 2014
    Last Updated
    November 6, 2014
    Sponsor
    Rigshospitalet, Denmark
    search

    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

    We'll reach out to this number within 24 hrs