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

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

Detailed Description
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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.

Official Title
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Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure

Conditions
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Degenerative Diseases, Nervous System

Intervention / Treatment
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* Device: PMD-200
* Diagnostic Test: SLR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: degenerative lumbar spine disease<br>patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200 | Device: PMD-200<br>* 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)<br>Diagnostic Test: SLR<br>* With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, about one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, about one year |