SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

Study Overview
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Brief Summary
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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).

Official Title
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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
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Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: subcutaneous nerve stimulation
* Other: Optimized Medical Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SQS plus OMM<br>subcutaneous nerve stimulation plus optimized medical management | Device: subcutaneous nerve stimulation<br>* subcutaneous nerve stimulation plus optimized medical management<br>Other: Optimized Medical Management<br>* Optimized medical management<br>|
| Active Comparator: OMM<br>optimized medical management | Other: Optimized Medical Management<br>* Optimized medical management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Treatment on Reduction of Back Pain Intensity | 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in Back Pain Intensity | Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number. | 6 and 9 months | 
| Back Pain Responder Rate (≥50%) at 6 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 6-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. | 6 months | 
| Back Pain Responder Rate (≥30%) at 9 Months | Percentage of participants who responded to the treatment, where response was defined as ≥ 30% 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. | 9 months |