Pain Monitoring Using Plurality of Non-invasive Physiological Measurement
Condition: Pain
Study type: Interventional

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.
    

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.
    

Intervention name(s): Scanlaf Circulator and water bath; Medoc TSA 2000
Intervention type(s): Device; Device
Intervention description(s): Cold Pressor Test; Thermal stimuli pain
Other intervention name(s): Open Cold Water Bath; Medoc Advanced Medical Systems TSA-II System
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic