Trial Outcomes & Findings for To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research (NCT NCT01618942)

Results Overview

The value was calculated as a avarage value of different measurement sites

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

1 hour after the procedure

Results posted on

2014-04-24

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Male Subjects grouped by gender and applied with hand-held pressure algometer with differen	Female Subjects grouped by gender grouped by gender and applied with hand-held pressure algometer with differen
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=93 Participants	50 Participants n=4 Participants	100 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	24.3 years STANDARD_DEVIATION 1.3 • n=93 Participants	24.2 years STANDARD_DEVIATION 1.9 • n=4 Participants	24.2 years STANDARD_DEVIATION 1.6 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	50 Participants n=4 Participants	50 Participants n=27 Participants
Sex: Female, Male Male	50 Participants n=93 Participants	0 Participants n=4 Participants	50 Participants n=27 Participants
Region of Enrollment China	50 participants n=93 Participants	50 participants n=4 Participants	100 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 hour after the procedure

The value was calculated as a avarage value of different measurement sites

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Pressure Pain Threshold (PPT)With 1 cm2 Probe	2.61 kg/cm2 Standard Deviation 0.88	2.20 kg/cm2 Standard Deviation 0.73

PRIMARY outcome

Timeframe: 1 hour after the procedure

The value was calculated as a avarage value of different measurement sites

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Pressure Pain Tolerance (PTO) With 1cm2 Probe	5.13 kg/cm2 Standard Deviation 1.79	4.39 kg/cm2 Standard Deviation 1.52

PRIMARY outcome

Timeframe: 1 hour after the procedure

The value was calculated as a avarage value of different measurement sites

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Pressure Pain Threshold (PPT)With 0.1 cm2 Probe	1.61 kg/cm2 Standard Deviation 0.71	1.11 kg/cm2 Standard Deviation 0.49

PRIMARY outcome

Timeframe: 1 hour after the procedure

The value was calculated as a avarage value of different measurement sites

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Pressure Pain Threshold (PPT)With 0.01 cm2 Probe	0.45 kg/cm2 Standard Deviation 0.16	0.44 kg/cm2 Standard Deviation 0.23

PRIMARY outcome

Timeframe: 1 hour after the procedure

The value was calculated as a avarage value of different measurement sites

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Pressure Pain Tolerance (PTO) With 0.1cm2 Probe	3.19 kg/cm2 Standard Deviation 1.16	2.34 kg/cm2 Standard Deviation 0.90

PRIMARY outcome

Timeframe: 1 hour after the procedure

The value was calculated as a avarage value of different measurement sites

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Pressure Pain Tolerance (PTO) With 0.01cm2 Probe	0.92 kg/cm2 Standard Deviation 0.32	0.93 kg/cm2 Standard Deviation 0.39

SECONDARY outcome

Timeframe: 10 minutes after the procedure

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Time of Each Test Procedure	16.8 seconds Standard Deviation 5.3	14.2 seconds Standard Deviation 4.9

SECONDARY outcome

Timeframe: 10 minutes after the procedure

Outcome measures

Outcome measures
Measure	Male Subjects n=50 Participants grouped by gender	Female Subjects n=50 Participants grouped by gender
Measuring Values of Skinfold Thickness	3.4 millimeters Standard Deviation 1.1	4.3 millimeters Standard Deviation 1.3

Adverse Events

Male Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Female Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Xianwei Zhang

Huazhong University of Science&Technology

Phone: 027 83662853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place