To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01618942
First received: June 12, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This study was conducted to explore the influencing factors, subjects and testers' evaluation about pain measurement with hand-held pressure algometer with different size probes. Methods:100 healthy undergraduate students(50 males and 50 females) were recruited into this study. Pain measurement including pressure pain threshold (PPT) and pressure pain tolerance(PTO) was carried out by the hand-held pressure algometer with different size probes (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. We recorded subjects' skinfold thickness, time per test procedure, types of pain perception, receptivity and degree of accuracy as well as testers' level of laborious.


Condition Intervention
Pain
Device: pressure algometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Pressure Pain Threshold (PPT)With 1 cm2 Probe [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
    The value was calculated as a avarage value of different measurement sites

  • Pressure Pain Tolerance (PTO) With 1cm2 Probe [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
    The value was calculated as a avarage value of different measurement sites

  • Pressure Pain Threshold (PPT)With 0.1 cm2 Probe [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
    The value was calculated as a avarage value of different measurement sites

  • Pressure Pain Threshold (PPT)With 0.01 cm2 Probe [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
    The value was calculated as a avarage value of different measurement sites

  • Pressure Pain Tolerance (PTO) With 0.1cm2 Probe [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
    The value was calculated as a avarage value of different measurement sites

  • Pressure Pain Tolerance (PTO) With 0.01cm2 Probe [ Time Frame: 1 hour after the procedure ] [ Designated as safety issue: Yes ]
    The value was calculated as a avarage value of different measurement sites


Secondary Outcome Measures:
  • Time of Each Test Procedure [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
  • Measuring Values of Skinfold Thickness [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: male subjects
grouped by gender and applied pressure pain test
Device: pressure algometer
Experimental: female subjects
grouped by gender and applied pressure pain test
Device: pressure algometer

Detailed Description:

Subjects with the following diseases were excluded: known history of chronic disease, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, Pregnancy or at lactation period .

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Aged 20 to 30 The right hand is handedness Agreed to participate the research Not with known chronic disease Not taking analgesics within 3 months

Exclusion Criteria:

  • History of chronic pain Psychiatric diseases Diabetes mellitus Severe cardiovascular diseases Kidney or liver diseases Alcohol or drug abuse Heavy smoker Disagree to participate to the research
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01618942

Locations
China, Hubei
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Xianwei Zhang
Investigators
Study Director: Zhang Xianwei, Doctor Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Xianwei Zhang, Clinical Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01618942     History of Changes
Other Study ID Numbers: Pressure algometer
Study First Received: June 12, 2012
Results First Received: May 23, 2013
Last Updated: April 7, 2014
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on July 31, 2014