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

Completed

• Conditions: Failed Back Surgery Syndrome; Chronic Pain; Sciatica
• Interventions: Procedure: Awake; Procedure: Non-Awake

• Registration Number: NCT02284542
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-27
• Study Start: 2014-11-01
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-06
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with successful trial implant	Awake	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.
Patients with successful trial implant	Non-Awake	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.

Primary Outcome Measures

Name	Time	Method
Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods	24 weeks
Safety assessed by the number of adverse events	24 weeks

Secondary Outcome Measures

Name	Time	Method
Pain Location	24 weeks
Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation	24 weeks
Pain Evaluation	24 weeks

Trial Locations

Locations (4)

St. Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Penn State Hershey Neurosciences Institute; 🇺🇸 Hershey, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States