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 |
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.
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.
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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