Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.

Official Title
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Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Boston Scientific Precision Plus spinal cord stimulation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic intractable pain of the trunk and/or limbs Documented history of trunk and/or limb pain of at least 180 days Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations Subject is able to independently read and complete all questionnaires and/or assessments provided in English 18 years of age or older when written informed consent is obtained Subject signs a valid, Ethics Committee-approved informed consent form (ICF) provided in English Exclusion Criteria: Unable to operate the PrecisionPlus™ system Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine Is a high surgical risk Is diabetic Is immunocompromised Currently on any anticoagulant medications that cannot be discontinued during perioperative period Untreated major depression or untreated generalized anxiety disorder Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder Diagnosed with any major psychiatric disorder not specifically listed in previous two exclusion criterion Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care Current abuse of alcohol or illicit drugs Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s). Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pump, etc) or pacemaker or implantable cardiac defibrillator Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result document)

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham Stimulation<br>Sham subthreshold spinal cord stimulation therapy | Device: Boston Scientific Precision Plus spinal cord stimulation therapy<br>* Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system<br>|
| Active Comparator: Treatment 1<br>subthreshold spinal cord stimulation therapy | Device: Boston Scientific Precision Plus spinal cord stimulation therapy<br>* Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system<br>|
| Experimental: Treatment 2<br>subthreshold spinal cord stimulation therapy | Device: Boston Scientific Precision Plus spinal cord stimulation therapy<br>* Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief | Mean within-patient difference in average back pain intensity among treatment groups | 4,8,and 12 days post temporary lead(s) implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief Responder Rate | Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups | 4,8,and 12 days post temporary lead(s) implantation | 
| Leg Pain Reduction | Mean within-patient difference in average leg pain intensity among treatment groups | 4,8,and 12 days post temporary lead(s) implantation | 
| Disability | Mean within-patient difference in disability among treatment groups | 4,8,and 12 days post temporary lead(s) implantation | 
| Percent Pain Relief | Mean within-patient difference in overall percent pain relief among treatment groups | 4,8,and 12 days post temporary lead(s) implantation | 
| Quality of Life, as Measured by EQ-5D-5L | Mean within-patient difference in quality of life among treatment groups | 4,8,and 12 days post temporary lead(s) implantation |