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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01618942

Enrollment

100

Registered

2012-06-13

Start date

2012-06-30

Completion date

2012-12-31

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief 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.

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 .

Interventions

DEVICEpressure algometer

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pressure Pain Tolerance (PTO) With 0.01cm2 Probe	1 hour after the procedure	The value was calculated as a avarage value of different measurement sites
Pressure Pain Threshold (PPT)With 0.01 cm2 Probe	1 hour after the procedure	The value was calculated as a avarage value of different measurement sites
Pressure Pain Tolerance (PTO) With 0.1cm2 Probe	1 hour after the procedure	The value was calculated as a avarage value of different measurement sites
Pressure Pain Threshold (PPT)With 1 cm2 Probe	1 hour after the procedure	The value was calculated as a avarage value of different measurement sites
Pressure Pain Tolerance (PTO) With 1cm2 Probe	1 hour after the procedure	The value was calculated as a avarage value of different measurement sites
Pressure Pain Threshold (PPT)With 0.1 cm2 Probe	1 hour after the procedure	The value was calculated as a avarage value of different measurement sites

Secondary

Measure	Time frame
Measuring Values of Skinfold Thickness	10 minutes after the procedure
Time of Each Test Procedure	10 minutes after the procedure

Countries

China

Participant flow

Recruitment details

From June 2012 to December 2012, 100 health students were recruitmented in the Tongji Medical College, Huazhong University of Science&Technology, Wuhan China.

Pre-assignment details

There was no significant events and approaches for the overall study.

Participants by arm

Arm	Count
Male Subjects grouped by gender	50
Female Subjects grouped by gender	50
Total	100

Baseline characteristics

Characteristic	Female Subjects	Total	Male Subjects
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	50 Participants	100 Participants	50 Participants
Age, Continuous	24.2 years STANDARD_DEVIATION 1.9	24.2 years STANDARD_DEVIATION 1.6	24.3 years STANDARD_DEVIATION 1.3
Region of Enrollment China	50 participants	100 participants	50 participants
Sex: Female, Male Female	50 Participants	50 Participants	0 Participants
Sex: Female, Male Male	0 Participants	50 Participants	50 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 50	0 / 50
serious Total, serious adverse events	0 / 50	0 / 50