A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes

Study Overview
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Brief Summary
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The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.

Detailed Description
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The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

Official Title
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COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Conventional single source programming
* Device: Precision Spectra SCS System advanced programming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets RELIEF Registry criteria for inclusion Primary complaint of persistent or recurrent low back pain, with or without leg pain Signed a valid, IRB/EC-approved informed consent form Exclusion Criteria: Meets any RELIEF Registry criteria for exclusion

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Programming, then Advanced Programming<br>Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming. | Device: Conventional single source programming<br>* Precision Spectra SCS System using conventional single source programming.<br>Device: Precision Spectra SCS System advanced programming<br>* Precision Spectra SCS System using advanced programming<br>|
| Active Comparator: Advanced Programming, then Conventional Programming<br>Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming. | Device: Conventional single source programming<br>* Precision Spectra SCS System using conventional single source programming.<br>Device: Precision Spectra SCS System advanced programming<br>* Precision Spectra SCS System using advanced programming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Paresthesia Coverage ≥50% | Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported. | 7, 14 days post activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stimulation, implantable, pulse generator, back pain, chronic pain, leg pain