- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618942
To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research
April 7, 2014 updated by: Xianwei Zhang
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.
Study Overview
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 .
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: male subjects
grouped by gender and applied pressure pain test
|
|
|
Experimental: female subjects
grouped by gender and applied pressure pain test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold (PPT)With 1 cm2 Probe
Time Frame: 1 hour after the procedure
|
The value was calculated as a avarage value of different measurement sites
|
1 hour after the procedure
|
|
Pressure Pain Tolerance (PTO) With 1cm2 Probe
Time Frame: 1 hour after the procedure
|
The value was calculated as a avarage value of different measurement sites
|
1 hour after the procedure
|
|
Pressure Pain Threshold (PPT)With 0.1 cm2 Probe
Time Frame: 1 hour after the procedure
|
The value was calculated as a avarage value of different measurement sites
|
1 hour after the procedure
|
|
Pressure Pain Threshold (PPT)With 0.01 cm2 Probe
Time Frame: 1 hour after the procedure
|
The value was calculated as a avarage value of different measurement sites
|
1 hour after the procedure
|
|
Pressure Pain Tolerance (PTO) With 0.1cm2 Probe
Time Frame: 1 hour after the procedure
|
The value was calculated as a avarage value of different measurement sites
|
1 hour after the procedure
|
|
Pressure Pain Tolerance (PTO) With 0.01cm2 Probe
Time Frame: 1 hour after the procedure
|
The value was calculated as a avarage value of different measurement sites
|
1 hour after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time of Each Test Procedure
Time Frame: 10 minutes after the procedure
|
10 minutes after the procedure
|
|
Measuring Values of Skinfold Thickness
Time Frame: 10 minutes after the procedure
|
10 minutes after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zhang Xianwei, Doctor, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 12, 2012
First Submitted That Met QC Criteria
June 12, 2012
First Posted (Estimate)
June 13, 2012
Study Record Updates
Last Update Posted (Estimate)
April 24, 2014
Last Update Submitted That Met QC Criteria
April 7, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Pressure algometer
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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