Chronic Low Back Pain Clinical Trial
Official title:
Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.
This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach. Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: - Test treatment group with SGX-SCS programming approach - Control treatment group with Standard SCS programming approach Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study. ;
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