Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Study Overview
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Brief Summary
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To determine the best parameters with various leads to cover back and leg pain and provide best pain relief

Detailed Description
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Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.

Official Title
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Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: preset program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: spinal cord stimulator implant within last 3 weeks NRS > 6 at least 22 years old patients who agree not to add or increase their pain medications during the study Exclusion Criteria: patients with prior spinal cord stimulators pregnancy infusion pump history of substance abuse or dependency in last 6 months

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: program 1<br>preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs | Device: preset program<br>* Change to different present program using epidural and peripheral lead to cover pain<br>* Other names: epidural and peripheral lead to cover pain (Spinal Cord Stimulator);|
| Active Comparator: program 2<br>preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs | Device: preset program<br>* Change to different present program using epidural and peripheral lead to cover pain<br>* Other names: epidural and peripheral lead to cover pain (Spinal Cord Stimulator);|
| Active Comparator: program 3<br>preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs | Device: preset program<br>* Change to different present program using epidural and peripheral lead to cover pain<br>* Other names: epidural and peripheral lead to cover pain (Spinal Cord Stimulator);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (Pain) | 0 (no pain)- 10 (worst pain imaginable) | Weeks 4, 6 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | percentage of pain relief- self report | weeks 4, 6, and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back pain, neuromodulation, spinal peripheral neuromodulation, spinal cord stimulation, postlaminectomy pain syndrome