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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
17
Precision Spectra SCS System using conventional single source programming.
Precision Spectra SCS System using advanced programming
Physicians Research Group, LLC
Phoenix, Arizona, United States
Albany Medical Center
Albany, New York, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
Spine Team Texas
Rockwall, Texas, United States
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.
Time frame: 7, 14 days post activation
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