Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
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|ClinicalTrials.gov Identifier: NCT03389048|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Diseases, Nervous System||Device: PMD-200 Diagnostic Test: SLR||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure|
|Actual Study Start Date :||November 13, 2017|
|Estimated Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Experimental: degenerative lumbar spine disease
patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200
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)
Diagnostic Test: SLR
With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.
- discrimination between nonpainful period to painful period [ Time Frame: Through study completion, about one year ]To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test
- Correlates with changes in pain levels [ Time Frame: Through study completion, about one year ]To demonstrate that the NoL Index is correlates with changes in pain levels of the subject prior and following SLR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389048
|Contact: Merav Gat, M.Sc.||+972-73-7690321 ext firstname.lastname@example.org|
|Galil Medical Center||Recruiting|
|Contact: Reut Peled +972-546230889|
|Principal Investigator:||Jean Soustiel, Prof.||Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel|