Clinical trial NCT02284542: NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
Official title: NAPS (Non-awake Versus Awake Placement of Spinal Cord Stimulators) Study for the Evaluation of Awake and Non-awake Methods of SCS Paddle Lead Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Sciatica
Failed Back Surgery Syndrome
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2014-11-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.

Brief summary: The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator.

Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.


Eligibility criteria: Inclusion Criteria:

* Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
* Sign informed consent

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: Safety assessed by the number of adverse events
timeFrame: 24 weeks
measure: Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods
timeFrame: 24 weeks
Secondary outcomes:
measure: Pain Evaluation
timeFrame: 24 weeks
measure: Pain Location
timeFrame: 24 weeks
measure: Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Neurosciences Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Principal Investigator
name: Steven Falowski, MD
role: PRINCIPAL_INVESTIGATOR
References: