NCT03389048

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

May 6, 2021

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

December 21, 2017

Last Update Submit

May 2, 2021

Conditions

Degenerative Diseases, Nervous System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlates with changes in pain levels

    Through study completion, about one year

Study Arms (1)

degenerative lumbar spine disease

EXPERIMENTAL

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

Device: PMD-200Diagnostic Test: SLR

Interventions

PMD-200DEVICE

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)

degenerative lumbar spine disease
SLRDIAGNOSTIC_TEST

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

degenerative lumbar spine disease

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The subject has a bi-lateral degenerative lumbar spine disease
  • The subject is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galil Medical Center

Nahariya, Israel

Location

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Jean Soustiel, Prof.

    Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 3, 2018

Study Start

March 8, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

May 6, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)