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

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