Spinal Cord Stimulation (SCS) Therapy Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.

Official Title
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Spinal Cord Stimulation (SCS) Therapy Study

Conditions
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Failed Back Surgery Syndrome, Degenerative Disk Disease, Epidural Fibrosis, Arachnoiditis, Radiculopathies

Intervention / Treatment
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* Device: Therapy Setting 1 (Medtronic)
* Device: Therapy Setting 2 (Medtronic)
* Device: Therapy Setting 3 (Medtronic)
* Device: Therapy Setting 4 (Medtronic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 22 years of age or older at the time of informed consent Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain Implanted with one or more Medtronic leads located in the epidural space within the thoracic area Receiving some level of pain relief with current SCS therapy On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications Read and understand English without assistance Willing and able to comply with all study procedures, study visits, and be available for the duration of the study Exclusion Criteria: Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.) Implanted with both a surgical and percutaneous lead Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation Has had any of the following procedures: Neuroablative procedure within six months Neurolytic block within two months Injection therapy for pain within four weeks Sympathetic block within two weeks Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study Has an untreated psychiatric comorbidity Has serious drug-related behavioral issues Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study Participating or planning to participate in another clinical trial while enrolled in this study

Ages Eligible for Study
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Minimum Age: 22 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RestoreSensor or RestoreUltra Setting 1<br>Therapy Setting 1 | Device: Therapy Setting 1 (Medtronic)<br>* RestoreSensor or RestoreUltra Setting 1<br>|
| Active Comparator: RestoreSensor or RestoreUltra Setting 2<br>Therapy Setting 2 | Device: Therapy Setting 2 (Medtronic)<br>* Medtronic RestoreSensor or RestoreUltra Setting 2<br>|
| Active Comparator: RestoreSensor or RestoreUltra Setting 3<br>Therapy Setting 3 | Device: Therapy Setting 3 (Medtronic)<br>* Medtronic RestoreSensor or RestoreUltra Setting 3<br>|
| Sham Comparator: RestoreSensor or RestoreUltra Setting 4<br>Therapy Setting 4 | Device: Therapy Setting 4 (Medtronic)<br>* Medtronic RestoreSensor or RestoreUltra Setting 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale - Leg pain |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory - Pain severity |  | 12 weeks | 
| Brief Pain Inventory - Pain interference |  | 12 weeks | 
| Quantitative Sensory Testing - Vibration threshold |  | 12 weeks | 
| Quantitative Sensory Testing - Electrical stimuli tolerance |  | 12 weeks | 
| Numeric Pain Rating Scale - Back pain |  | 12 weeks |