NCT01711619TerminatedNot Applicable
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- MedtronicNeuro
- Enrollment
- 162
- Locations
- 26
- Primary Endpoint
- Effectiveness of Treatment on Reduction of Back Pain Intensity
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SQS plus OMM
Experimental
subcutaneous nerve stimulation plus optimized medical management
Intervention: subcutaneous nerve stimulation (Device)
SQS plus OMM
Experimental
subcutaneous nerve stimulation plus optimized medical management
Intervention: Optimized Medical Management (Other)
OMM
Active Comparator
optimized medical management
Intervention: Optimized Medical Management (Other)
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.
Secondary Outcomes
- Average Change in Back Pain Intensity(6 and 9 months)
- Back Pain Responder Rate (≥50%) at 6 Months(6 months)
- Back Pain Responder Rate (≥30%) at 9 Months(9 months)
Investigators
Study Sites (26)
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