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

NCT ID: NCT03389048

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-08
• Study Completion Date: 2019-11-30

Brief Summary

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

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.

Conditions

Degenerative Diseases, Nervous System

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

degenerative lumbar spine disease

patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200

Group Type: EXPERIMENTAL

PMD-200

Intervention Type: DEVICE

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)

SLR

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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)

Intervention Type: DEVICE

SLR

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medasense Biometrics Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Soustiel, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

Locations

Galil Medical Center

Nahariya, , Israel

Countries

Israel

Other Identifiers

CLI-16-04

Identifier Type: -

Identifier Source: org_study_id