OPTIONS Spinal Cord Stimulation Programming Parameters

Study Overview
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Brief Summary
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The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Detailed Description
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Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study. The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Official Title
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A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.

Conditions
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Pain, Intractable

Intervention / Treatment
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* Device: Spinal Cord Stimulation (SCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain) Willing and able to provide a signed and dated informed consent At least 18 years old at the time of informed consent Willing and able to attend visits and comply with the study protocol Capable of using the patient programmer and recharging the neurostimulator Willing to not increase pain medications from baseline through the 3-Month Visit Exclusion Criteria: Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results. Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol. Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system Implanted with a cardiac device (e.g., pacemaker, defibrillator)

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 |
| --- | --- |
| Other: Open label treatment<br>Spinal Cord Stimulation (SCS) | Device: Spinal Cord Stimulation (SCS)<br>* SCS programming options<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be). | From baseline to 3 months post device activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change | Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference). | From baseline to 3 months post device activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, intractable pain, failed back surgery syndrome