Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)

MedtronicNeuro26 sites in 10 countries162 target enrollmentNovember 2012

ConditionsFailed Back Surgery Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Failed Back Surgery Syndrome
Sponsor: MedtronicNeuro
Enrollment: 162
Locations: 26
Primary Endpoint: Effectiveness of Treatment on Reduction of Back Pain Intensity
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

February 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MedtronicNeuro

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
•≥ 18 years of age at time of informed consent
•Willing and available to attend visits as scheduled and to comply with the study protocol
•Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
•Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol
•Diagnosed with FBSS (i.e.):
•Has had persistent pain for 6 months following most recent anatomically correct, successful surgery AND
•There are no further therapeutic surgical options available as assessed by appropriate investigation
•Back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical))
•Is an appropriate implant candidate for the SQS system

Exclusion Criteria

•Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
•Evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator
•Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
•Spinal instability or anatomic compression that requires further surgery
•Spinal fusion at more than 3 vertebral levels
•Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
•Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
•History of coagulation disorder or lupus erythematosus
•Involved in current litigation regarding back pain

Outcomes

Primary Outcomes

Effectiveness of Treatment on Reduction of Back Pain Intensity

Time Frame: 9 months

Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.