Clinical trial NCT03606187: Stimgenics Open-Label, Post Market Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Back Pain, Spinal Cord Stimulation
Lead sponsor: Stimgenics LLC
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
2. Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
3. Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
4. Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
5. Be 18 years of age or older at the time of enrollment
6. Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
7. Be willing to not increase pain medications from baseline through the 3-Month Visit
8. Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
2. Be concurrently participating in another clinical study
3. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
4. Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
5. Has mechanical spine instability as determined by the Investigator

Primary outcomes:
measure: The Percentage of Individual Responders
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Individual Responders
timeFrame: 3 months
measure: Change in Back Pain Score
timeFrame: 3 months
measure: 6 Months Comparison of Back Pain Treatment Success
timeFrame: 6 months
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: StimGenics
state: Illinois
Study officials:
References: