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

Medasense

Status

Terminated

Conditions

Degenerative Diseases, Nervous System

Treatments

Device: PMD-200

Diagnostic Test: SLR

Study type

Interventional

Funder types

Other

Identifiers

NCT03389048

CLI-16-04

Details and patient eligibility

About

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

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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