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

Not Applicable

Terminated

• Conditions: Degenerative Diseases, Nervous System
• Interventions: Device: PMD-200; Diagnostic Test: SLR

• Registration Number: NCT03389048
• Lead Sponsor: Medasense Biometrics Ltd

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.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-03
• Study Start: 2018-03-08
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-03
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
discrimination between nonpainful period to painful period	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

Secondary Outcome Measures

Name	Time	Method
Correlates with changes in pain levels	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.

Trial Locations

Locations (1)

Galil Medical Center; 🇮🇱 Nahariya, Israel