Chronic Low Back Pain
Conditions
Keywords
Back Pain, Spinal Cord Stimulation
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.
Interventions
DEVICEStimgenics SCS Programming Approach
Stimgenics SCS Programming approach Using Intellis(TM) SCS system
DEVICEStandard SCS Programming Approach
Standard SCS Programming approach using Intellis(TM) SCS system
Sponsors
Stimgenics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Individual Responders | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Individual Responders | 3 months | The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority |
| Change in Back Pain Score | 3 months | 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. |
| 6 Months Comparison of Back Pain Treatment Success | 6 months | 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 |
| Oswestry Disability Index (ODI) | 3 months | Oswestry Disability Index (ODI) evaluated at 3 months visit |
| Adverse Events | 3 months | Frequency of treatment emergent adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Arm Subjects randomized to this arm will receive test treatment
Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system | 67 |
| Control Arm Subjects randomized to this arm will receive control treatment
Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system | 61 |
| Total | 128 |
Baseline characteristics
| Characteristic | Control Arm | Total | Test Arm |
|---|---|---|---|
| Age, Continuous | 60.66 years STANDARD_DEVIATION 11.77 | 60.98 years STANDARD_DEVIATION 11.93 | 61.25 years STANDARD_DEVIATION 12.16 |
| Back Pain | 7.35 cm STANDARD_DEVIATION 1.26 | 7.3 cm STANDARD_DEVIATION 1.38 | 7.25 cm STANDARD_DEVIATION 1.49 |
| Leg Pain | 6.58 cm STANDARD_DEVIATION 2.06 | 6.38 cm STANDARD_DEVIATION 2.35 | 6.2 cm STANDARD_DEVIATION 2.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 110 Participants | 60 Participants |
| Sex: Female, Male Female | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Male | 27 Participants | 60 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 61 |
| other Total, other adverse events | 0 / 67 | 0 / 61 |
| serious Total, serious adverse events | 0 / 67 | 2 / 61 |
Outcome results
Primary
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
Population: Intent to treat population (all subjects randomized)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Arm | The Percentage of Individual Responders | 80.9 percentage of responders |
| Control Arm | The Percentage of Individual Responders | 50.9 percentage of responders |
Secondary
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
Secondary
Adverse Events
Frequency of treatment emergent adverse events
Time frame: 3 months
Secondary
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
Secondary
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) evaluated at 3 months visit
Time frame: 3 months
Secondary
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