Pain Monitoring Using Plurality of Non-invasive Physiological Measurement

Pain Clinical Trial

Official title:

A Single-blind Randomized Clinical Trial to Assess the Efficacy of the Medasense's Non-Invasive Pain Monitor in Estimating the Pain Level Comparing to the Pain Stimuli and the Reported Pain Level on Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914173
• Other study ID #: Medasense001
• Status: Completed
• Phase: N/A
• First received: June 3, 2009
• Last updated: January 27, 2010
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.

Description:

Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. However, since a great extent of pain is a subjective phenomenon, it has frequently defied objective, quantitative measurement. Traditionally, physicians have had to assess a patient's pain by relying on the patient's own description. Self-description is not only subjective by definition; it is often inaccurate, in part because it is difficult for subjects to precisely articulate their pain while in the midst of a pain experience. Moreover, the report might be impossible when the subject cannot communicate

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy participant that response to pain stimuli

• Blood Pressure < (90,140), Heart Rate < 100pps

• Patient informed consent must be obtained

Exclusion Criteria:

• Not responding to pain stimuli (Hypoalgesia)

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Scanlaf Circulator and water bath
Cold Pressor Test
• Medoc TSA 2000
Thermal stimuli pain

Locations

Country	Name	City	State
Israel	Pain Relief Unit,Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between the pain monitoring device results and the subjective pain report measured by the numeric pain scale to a given pain stimulus (heat and cold)		one year	No
Secondary	Collect database to implement the algorithm for the pain monitor to differ between different pain levels.		one year	No