Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs

Study Overview
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Brief Summary
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The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.

Official Title
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A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.

Conditions
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Chronic Pain

Intervention / Treatment
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* Procedure: Burst stimulation
* Device: Prodigy system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain Patient is considered by the investigator as a candidate for implantation of a SCS system Patient is ≥ 18 years of age Patient must be willing and able to comply with study requirements Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form Exclusion Criteria: Patient is immune-compromised Patient has history of cancer requiring active treatment in the last 6 months Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months Patients with a SCS system or implantable infusion pump implanted previously Patient has a life expectancy of less than one year Patient is pregnant or is planning to become pregnant during the duration of the investigation Patient is unable to comply with the follow up schedule Patient needing legally authorized representative Patient unable to read and write Patient is currently participating in another clinical investigation with an active treatment arm

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Burst stimulation<br>At permanent implant with the Prodigy system, patients will be programmed with Burst stimulation | Procedure: Burst stimulation<br> <br> Device: Prodigy system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the percentage of pain relief at the 3-month visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious adverse events (SAEs) and/or procedure/device-related adverse events ((S)ADEs) |  | from enrollment to 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCS, Burst stimulation