NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

St. Luke's Hospital, Pennsylvania

Status: Completed

Conditions: Chronic Pain; Sciatica; Failed Back Surgery Syndrome

Treatments: Procedure: Non-Awake; Procedure: Awake

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02284542

2014-81

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 1 patient group

Patients with successful trial implant

Description:

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.

Treatment:

Procedure: Awake

Procedure: Non-Awake