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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Stimgenics SCS Programming approach Using Intellis(TM) SCS system
Standard SCS Programming approach using Intellis(TM) SCS system
StimGenics
Bloomington, Illinois, United States
The Percentage of Individual Responders
Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS).
Time frame: 3 months
Percentage of Individual Responders
The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority
Time frame: 3 months
Change in Back Pain Score
Comparison of change from Baseline in back pain score (using Visual Analog Scale 0.0-10.0cm) determined at the 3- and 6-month visit after device activation, between test and control in a statistical test of non-inferiority. This is calculated as: Change from Baseline in Back Pain VAS = 3-Month Visit Pain VAS - Baseline Pain VAS.
Time frame: 3 months
6 Months Comparison of Back Pain Treatment Success
Comparison of Back Pain Treatment Success (responder rate), measured as subjects with at least a 50% reduction in Back Pain Visual Analog Scale (VAS), evaluated at 6 months after device activation, between test and control
Time frame: 6 months
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) evaluated at 3 months visit
Time frame: 3 months
Adverse Events
Frequency of treatment emergent adverse events
Time frame: 3 months
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