PainNCT01618942

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

A study testing pressure algometer in people with Pain, run by Xianwei Zhang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: pressure algometer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: Jun 2012to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030

Other trials in China

About this study

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.

Read the 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 .

Conditions: Pain
Being tested: pressure algometer
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pressure algometerDevice

Study groups in NCT01618942
Study group	Role	What they receive
male subjects	Experimental	grouped by gender and applied pressure pain test Receives: Device: pressure algometer
female subjects	Experimental	grouped by gender and applied pressure pain test Receives: Device: pressure algometer

What is being measured

The primary outcome is the main question the study is designed to answer.

Pressure Pain Threshold (PPT)With 1 cm2 Probe
The value was calculated as a avarage value of different measurement sites
Measured: 1 hour after the procedure
Pressure Pain Tolerance (PTO) With 1cm2 Probe
The value was calculated as a avarage value of different measurement sites
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 hour after the procedure

Secondary outcomes (2)

Time of Each Test Procedure
Measured: 10 minutes after the procedure
Measuring Values of Skinfold Thickness
Measured: 10 minutes after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2012

First posted13 Jun 2012 (estimated)
Study startJun 2012
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01618942
Sponsor's protocol ID: Pressure algometer
Status last verified: Apr 2014
First submitted: 12 Jun 2012
Last updated: 24 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research
ClinicalTrials.gov ID: NCT01618942
Acronym / sponsor ID: Pressure algometer
Conditions: Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Xianwei ZhangUniversity, hospital or other
Study start: Jun 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 13 Jun 2012 (estimated)
Results: Posted 26 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
male subjects	Experimental	Device: pressure algometergrouped by gender and applied pressure pain test
female subjects	Experimental	Device: pressure algometergrouped by gender and applied pressure pain test

Who may qualify

Ages: 20 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pressure algometer	Device	female subjects, male subjects

Primary outcome

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
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
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
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
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
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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 26 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Male Subjects	50	50
Female Subjects	50	50

Primary outcome: Pressure Pain Threshold (PPT)With 1 cm2 Probe

Time frame: 1 hour after the procedure. Mean (Standard Deviation). Unit: kg/cm2

Measure	Male Subjects n = 50	Female Subjects n = 50
Value	2.61 (0.88)	2.20 (0.73)

Primary outcome: Pressure Pain Tolerance (PTO) With 1cm2 Probe

Time frame: 1 hour after the procedure. Mean (Standard Deviation). Unit: kg/cm2

Measure	Male Subjects n = 50	Female Subjects n = 50
Value	5.13 (1.79)	4.39 (1.52)

Primary outcome: Pressure Pain Threshold (PPT)With 0.1 cm2 Probe

Time frame: 1 hour after the procedure. Mean (Standard Deviation). Unit: kg/cm2

Measure	Male Subjects n = 50	Female Subjects n = 50
Value	1.61 (0.71)	1.11 (0.49)

Primary outcome: Pressure Pain Threshold (PPT)With 0.01 cm2 Probe

Time frame: 1 hour after the procedure. Mean (Standard Deviation). Unit: kg/cm2

Measure	Male Subjects n = 50	Female Subjects n = 50
Value	0.45 (0.16)	0.44 (0.23)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Male Subjects	0 of 50 (0%)	0 of 50 (0%)	Not reported
Female Subjects	0 of 50 (0%)	0 of 50 (0%)	Not reported

Limitations and caveats (from the sponsor): There was no significant limitation in the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhang Xianwei, Doctor study director

Huazhong University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing pressure algometer in people with Pain, run by Xianwei Zhang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (PPT)With 1 cm2 Probe (time frame: 1 hour after the procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01618942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.