NCT01618942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 26, 2013

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

June 12, 2012

Results QC Date

May 23, 2013

Last Update Submit

April 7, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (6)

  • 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

  • Pressure Pain Tolerance (PTO) With 1cm2 Probe

    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

    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

    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

    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

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

    1 hour after the procedure

Secondary Outcomes (2)

  • Time of Each Test Procedure

    10 minutes after the procedure

  • Measuring Values of Skinfold Thickness

    10 minutes after the procedure

Study Arms (2)

male subjects

EXPERIMENTAL

grouped by gender and applied pressure pain test

Device: pressure algometer

female subjects

EXPERIMENTAL

grouped by gender and applied pressure pain test

Device: pressure algometer

Interventions

pressure algometerDEVICE
female subjectsmale subjects

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

There was no significant limitation in the study.

Results Point of Contact

Title
Xianwei Zhang
Organization
Huazhong University of Science&Technology
ourpain@163.com
027 83662853

Study Officials

  • Zhang Xianwei, Doctor

    Huazhong University of Science and Technology

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 13, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 24, 2014

Results First Posted

November 26, 2013

Record last verified: 2014-04

Locations

CN(1)