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



Status:Terminated
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/21/2018
Start Date:February 2015
End Date:October 2016

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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

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.

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.

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
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