An interventional study of Control - Conventional SCS and Test - Stimgenics SCS in Chronic Pain, sponsored by Stimgenics LLC. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Stimgenics LLC · Not applicable, Interventional, and Treatment
Trialing of PM modulation therapy in patients with chronic intractable low back pain
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Stimgenics LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Device: Control - Conventional SCS
1 day where no stimulation is provided
Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Device: Test - Stimgenics SCS
Conventional SCS Parameters
Stimgenics SCS Parameters
Change in Pain Relative to Baseline and After a Trial Period
Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.
Time frame: Baseline and 4 days plus or minus 1 days
| Milestone | Single Arm With Multiple Periods |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Milestone | Single Arm With Multiple Periods |
|---|---|
| Started | 24 |
| Completed | 23 |
| Not completed | 1 |
| Milestone | Single Arm With Multiple Periods |
|---|---|
| Started | 23 |
| Completed | 20 |
| Not completed | 3 |
Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.
| Score on a 11 point scale | Conventional SCS | Stimgenics SCS |
|---|---|---|
| Change in Pain Relative to Baseline and After a Trial Period | 4.2 ± 2.0 | 2.4 ± 1.8 |
Collected over 1-10 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional SCS | 0/25 (0%) | 1/25 (4%) | 3/25 (12%) |
| Washout Period | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Stimgenics SCS | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Conventional SCS | Washout Period | Stimgenics SCS |
|---|---|---|---|
| Epidural abscessInfections and infestations | 1/25 | 0/20 | 0/20 |
| Event | Conventional SCS | Washout Period | Stimgenics SCS |
|---|---|---|---|
| Lead movementSurgical and medical procedures | 3/25 | 0/20 | 0/20 |
Chronic Back Pain Patients
| Age, Continuous(years) | Enrolled Patients |
|---|---|
| Mean | 62.4 ± 11.5 |
| Sex: Female, Male(Participants) | Enrolled Patients |
|---|---|
| Female | 15 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Enrolled Patients |
|---|
| Back Pain on Numeric Pain Rating Scale (11-point rating scale)(Score on a scale) | Enrolled Patients |
|---|---|
| Mean | 7.4 ± 1.2 |
| Leg Pain Numeric Pain Rating Scale (11-point rating scale)(Score on a scale) | Enrolled Patients |
|---|---|
| Mean | 4 ± 2.8 |
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Stimgenics LLC