Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure

Medasense Biometrics Ltd21 enrolled

Overview

Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure

The proposed study is design to further demonstrates the capability of the Nociception Level, (NoL) Index in identify and discriminate between painful event and non-painful period following pain stimulus of Straight Leg Raising (SLR) test in patients with degenerative lumbar spine disease. This feasibility study may provide first indication for a validation method that will be able to evaluate the outcome of a surgical procedure within the degenerative lumbar spine patient. Currently, there is lack of understanding of long-term outcomes after such surgeries. In this study, the investigators plan to demonstrate that the NoL Index may serve as an indicator to the surgical procedure outcome. It will compare the objective measurement of the NoL to the patient Visual Analogue Scale (VAS) score and disability questionnaire that will characterize the subject pain perception prior and following the surgical procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Degenerative Diseases, Nervous System

Interventions

PMD-200DEVICE

The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)

SLRDIAGNOSTIC_TEST

With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 18 and less than 65 (18 \< Age \< 65). * The subject suffer from unilateral degenerative lumbar spine disease * The subject suffer from leg pain only in one leg, while no pain in the other leg. * The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease * A signed Informed Consent Form (ICF) has been obtain from the subject Exclusion Criteria: * The subject has a bi-lateral degenerative lumbar spine disease * The subject is pregnant

Locations (1)

Galil Medical Center

Nahariya, Israel

Outcomes

Primary Outcomes

discrimination between nonpainful period to painful period

To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test

Time frame: Through study completion, about one year

Secondary Outcomes

Correlates with changes in pain levels

To demonstrate that the NoL Index is correlates with changes in pain levels of the subject prior and following SLR.

Time frame: Through study completion, about one year

Data from ClinicalTrials.gov

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