Chronic Back Pain
Conditions
Brief summary
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach. The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.
Detailed description
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional 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 DTM-SCS programming approach * Control treatment group with Conventional 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. There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit. Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization. This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint. The expected total duration of this study is approximately 32 months.
Interventions
DEVICEDTM Programming
DTM-SCS programming
DEVICEConventional SCS programming
Conventional SCS programming
Sponsors
SGX Nova LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * Test treatment group with DTM-SCS programming approach * Control treatment group with Conventional 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
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 pain with or without leg pain) 2. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment 3. Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment 4. 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. 5. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent. 6. Be 18 years of age or older at the time of enrollment 7. Be on a stable pain medication regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study 8. Be willing to not increase pain medications from baseline through the 3-Month Visit 9. Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion criteria
1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) 2. Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator 3. Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, as determined by the Investigator 4. Be concurrently participating in another clinical study 5. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc. 6. Has a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 7. Has mechanical spine instability as determined by the Investigator 8. Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief 9. Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator 10. Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim 11. Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy | 3 months | The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment. |
Countries
United States
Participant flow
Pre-assignment details
121 subjects met inclusion and exclusion criteria after enrollment were randomized (5 subjects failed screening). 105 subjects successfully randomized subjects completed the trial phase and were included in the Modified Intent to Treat Analysis.
Participants by arm
| Arm | Count |
|---|---|
| DTM-SCS Programming Group DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. | 51 |
| Conventional SCS Programming Group Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals. | 54 |
| Total | 105 |
Baseline characteristics
| Characteristic | DTM-SCS Programming Group | Conventional SCS Programming Group | Total |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 13.5 | 59.6 years STANDARD_DEVIATION 12.1 | 61.2 years STANDARD_DEVIATION 12.8 |
| Back Pain VAS | 7.9 units on a scale STANDARD_DEVIATION 1 | 8.0 units on a scale STANDARD_DEVIATION 1.1 | 8.0 units on a scale STANDARD_DEVIATION 1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 51 participants | 54 participants | 105 participants |
| Sex: Female, Male Female | 29 Participants | 33 Participants | 62 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 54 |
| other Total, other adverse events | 0 / 51 | 0 / 54 |
| serious Total, serious adverse events | 1 / 51 | 2 / 54 |
Outcome results
Primary
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.
Time frame: 3 months
Population: Modified Intent to Treat (mITT): All successfully randomized subjects who complete the Trial Phase. Failed trial subjects and subjects that withdrew due to insufficient pain relief carry forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTM-SCS Programming Group | Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy | 93.5 percentage of participants |
| Conventional SCS Programming Group | Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy | 36.4 percentage of participants |