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

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

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

Study Overview

• Status: Terminated
• Conditions: Degenerative Diseases, Nervous System
• Intervention / Treatment: Device: PMD-200; Diagnostic test: SLR

Detailed Description

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
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel
    • Galil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: degenerative lumbar spine disease; patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Investigators: Principal Investigator: Jean Soustiel, Prof., Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: CLI-16-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No