High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

Study Overview
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Brief Summary
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To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

Detailed Description
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This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Official Title
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Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Low Rate Stimulation
* Device: High Rate Stimulation


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, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English Exclusion Criteria: Unable to operate the Precision Plus 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 CE7 or CE8 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 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 (Implantable Pulse Generators (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 documented)

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 |
| --- | --- |
| Experimental: Low Rate Followed By High Rate<br>The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days. | Device: Low Rate Stimulation<br>* Stimulation was given at a rate of 2 Hz.<br>Device: High Rate Stimulation<br>* Stimulation was given at a rate of 1200 Hz.<br>|
| Experimental: High Rate Followed By Low Rate<br>The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days. | Device: Low Rate Stimulation<br>* Stimulation was given at a rate of 2 Hz.<br>Device: High Rate Stimulation<br>* Stimulation was given at a rate of 1200 Hz.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Back Pain Intensity | Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation. | For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject). |