Pain Monitoring Using Plurality of Non-invasive Physiological Measurement

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Scanlaf Circulator and water bath; Device: Medoc TSA 2000

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Pain Relief Unit,Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Scanlaf Circulator and water bath; Cold Pressor Test; Other Names: Open Cold Water Bath; Device: Medoc TSA 2000; Thermal stimuli pain; Other Names: Medoc Advanced Medical Systems TSA-II System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Collect database to implement the algorithm for the pain monitor to differ between different pain levels.	one year

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Investigators: Principal Investigator: Elon Eisenberg, Prof., Pain Relief Unit, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Estimate): January 28, 2010
• Last Update Submitted That Met QC Criteria: January 27, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: Medasense001