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

Degenerative Diseases, Nervous System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03389048
• Other study ID #: CLI-16-04
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Diseases, Nervous System
• Nervous System Diseases
• Neurodegenerative Diseases

Intervention

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.

Locations

Country	Name	City	State
Israel	Galil Medical Center	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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