An Implantable Spinal Cord Stimulation Pain Management System

Study Overview
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Brief Summary
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There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

Detailed Description
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This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Dailed back surgery syndrome, intractable low backpain and leg pain.

Official Title
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Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System

Conditions
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Chronic Pain, Pain, Intractable, Pain, Back Pain, Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: Precision SCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain. Be an appropriate candidate for surgery. Be capable of giving informed consent. Be capable and willing to follow all study related procedures. Exclusion Criteria: Have an inability to operate the system either by self or care-giver. Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study. Have any implanted electrical devices, regardless of whether active or inactive. Have any active implantable device regardless of whether stimulation is ON or OFF.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precision SCS<br>Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system | Device: Precision SCS<br>* Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.<br>* Other names: PRECISION Spinal Cord Stimulator System (PRECISION System);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. | The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS. | 2 weeks post initial fitting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Chronic Pain, Neurostimulation