A Multi-Center Controlled Study to characterize the real-world outcomes of High Rate Spinal Cord Stimulation therapy using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System

Completed

• Conditions: continued back pain after surgery; Difficult to treat low back pain; 10041543; 10009720

• Registration Number: NL-OMON42937
• Lead Sponsor: Boston Scientific Group plc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-04-26
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

-Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
-No back surgery within 6 months prior to Screening
-Average low back pain intensity of 6 or greater on a 0-10 numerical rating scale during Screening (NRS) as evaluated by interview
-Baseline Oswestry Disability Index score >40 and <81
-18 years of age or older when written informed consent is obtained

Exclusion Criteria

-Average leg pain is greater than or equal to average low back pain during Screening (NRS).
-Radiographic evidence of spinal instability requiring fusion
-Require implantation of lead(s) in the cervical epidural space
-Requires implantation of paddle-style SCS lead(s) via a laminotomy and/or laminectomy
-Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Low back pain responder rate at 3 months post-activation as compared with<br /><br>Baseline. A responder is defined as *30% low back pain reduction from Baseline<br /><br>without change in opioids.</p><br>