NCT03389048

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medasense Biometrics Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-08
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2018-01-03
• Last updated: 2021-05-06

Locations

1 site across 1 country: Israel