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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618942
• Other study ID #: Pressure algometer
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: April 7, 2014
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• pressure algometer

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xianwei Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold (PPT)With 1 cm2 Probe	The value was calculated as a avarage value of different measurement sites	1 hour after the procedure	Yes
Primary	Pressure Pain Tolerance (PTO) With 1cm2 Probe	The value was calculated as a avarage value of different measurement sites	1 hour after the procedure	Yes
Primary	Pressure Pain Threshold (PPT)With 0.1 cm2 Probe	The value was calculated as a avarage value of different measurement sites	1 hour after the procedure	Yes
Primary	Pressure Pain Threshold (PPT)With 0.01 cm2 Probe	The value was calculated as a avarage value of different measurement sites	1 hour after the procedure	Yes
Primary	Pressure Pain Tolerance (PTO) With 0.1cm2 Probe	The value was calculated as a avarage value of different measurement sites	1 hour after the procedure	Yes
Primary	Pressure Pain Tolerance (PTO) With 0.01cm2 Probe	The value was calculated as a avarage value of different measurement sites	1 hour after the procedure	Yes
Secondary	Time of Each Test Procedure		10 minutes after the procedure	Yes
Secondary	Measuring Values of Skinfold Thickness		10 minutes after the procedure	Yes