Pain Monitoring Using Plurality of Non-invasive Physiological Measurement
NCT ID: NCT00914173
Last Updated: 2010-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-11-30
2009-10-31
Brief Summary
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Detailed Description
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Presently, in order to quantify pain, the care provider asks the patient to rate his/her pain intensity using one-dimensional scale usually scored from 0 to 10. This scale is known as Numeric Pain Scale. This and other measures are used by the care providers to estimate the correct treatment dose and or to track a treatment progress. Due to its impact on care provider decision to prescribe painkiller mediation, some patients also intentionally misrepresent the existence or extent of their pain. Yet, without any reliable basis for denying such prescriptions, physicians generally must assume that the claims are truthful, even when they may suspect a lack of sincerity. Otherwise, the care provider may be accused of inhumane treatment. Conversely, other patients may underreport their pain, again for a variety of reasons.
The presented clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. During the trial, up to 100 healthy young adults will be voluntarily inflicted by pain stimuli. The pain stimuli will be thermal heat pain stimulus and cold water pain stimulus applied with different intensities. Plurality of Non-Invasive Physiological Measurements will be recorded from volunteers and their Numeric Pain Scale reports will be monitored before, during and after the pain induction. Additional information such as age, gender, ethnicity, etc. will be collected as well. The collected database will be used to implement the algorithm that applies modern signal processing and machine learning methods in order to differentiate between different pain levels. The algorithm will be later integrated into pain monitoring device. The efficacy of the algorithm of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Pain/No Pain Stimuli
One Arm is used in this trial. The comparator is within the arm. The different types of stimuli levels and types are compared.
Scanlaf Circulator and water bath
Cold Pressor Test
Medoc TSA 2000
Thermal stimuli pain
Interventions
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Scanlaf Circulator and water bath
Cold Pressor Test
Medoc TSA 2000
Thermal stimuli pain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Blood Pressure \< (90,140), Heart Rate \< 100pps
* Patient informed consent must be obtained
Exclusion Criteria
* Over responding to pain stimuli (Hyperalgesia)
* Classifying non pain stimuli as painful event (Allodynia)
* Medication/drugs were taken in the last week
* Usage of chronic medication in the last 3 months (not including contraceptive pills)
* Alcohol usage during the last 48 hours
* Caffeine in the last 3 hours
* Pregnant women
* Inability to comply with the study protocol.
18 Years
40 Years
ALL
Yes
Sponsors
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Medasense Biometrics Ltd
OTHER
Responsible Party
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Rambam medical Center -The Pain palliation unit
Principal Investigators
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Elon Eisenberg, Prof.
Role: PRINCIPAL_INVESTIGATOR
Pain Relief Unit, Rambam Health Care Campus
Locations
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Pain Relief Unit,Rambam Medical Center
Haifa, , Israel
Countries
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Other Identifiers
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Medasense001
Identifier Type: -
Identifier Source: org_study_id