Pain Monitoring Using Plurality of Non-invasive Physiological Measurement

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.”

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.

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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.

Primary Measures

• 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)
  • Time Frame: one year
    Safety Issue?: No

Secondary Measures

• Collect database to implement the algorithm for the pain monitor to differ between different pain levels.
  • Time Frame: one year
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Medasense Biometrics Ltd Other

Overall Clinical Trial Officials and Contacts

Elon Eisenberg, Prof. Principal Investigator Pain Relief Unit, Rambam Health Care Campus  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00914173

Study ID Number: Medasense001

ClinicalTrials.gov Identifier: NCT00914173

Health Authority: Israel: Ministry of Health