CClinicalTrials.gg
CompletedNCT03110601Updated Apr 16, 2019Results posted

Study of PM Modulation Therapy in Trial Phase

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

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
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Study summary

Trialing of PM modulation therapy in patients with chronic intractable low back pain

02

Conditions studied

  • Chronic Pain

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03

In context

Chronic 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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
  2. Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months.
  3. Must be older than 18 years old.
  4. Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
  5. Appropriate candidate for spinal cord stimulation trial.
  6. Subjects must be on a stable dose of pain medication regimen for at least 1 month.
  7. Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test and must be using reliable contraception and must continue to use reliable contraception until study completion. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start. Patients who become pregnant or who have a spouse/significant other that becomes pregnant during the course of this study agree to report pregnancy to the study physician/staff.
  8. Must be able to comply with the requirement of study visits and follow-up and phone visits.
  9. Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.

Exclusion criteria

Exclusion Criteria:

  1. Systemic infection.
  2. Any active implanted device.
  3. Previous experience with SCS therapy either during a trial or fully implanted
  4. Evidence of serious neurological, psychological or psychiatric disorders.
  5. Mechanical spinal instability.
  6. Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
  7. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
  8. Human immunodeficiency virus (HIV) infection or a clinically significant infection.
  9. Patients who are undergoing or will undergo therapies or diagnostics that involve electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy, psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve stimulation.
  10. A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
  11. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
  12. Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
  13. Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
  14. Medical condition or pain in other body areas that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
  15. Concurrent participation in another clinical study.
  16. Involvement in an injury claim under current litigation or a pending or approved workers' compensation claim.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Control - Conventional SCS

    Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.

    Device: Control - Conventional SCS

  • No intervention
    Washout Period

    1 day where no stimulation is provided

  • Experimental
    Test - Stimgenics SCS

    Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.

    Device: Test - Stimgenics SCS

Interventions

  • DeviceControl - Conventional SCS

    Conventional SCS Parameters

  • DeviceTest - Stimgenics SCS

    Stimgenics SCS Parameters

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Apr 16, 2019
Limitations and caveats
Patients were evaluated during the trial phase.

Participant flow

Conventional SCS Parameters
Participant flow — Conventional SCS Parameters
MilestoneSingle Arm With Multiple Periods
Started25
Completed24
Not completed1
Washout Period
Participant flow — Washout Period
MilestoneSingle Arm With Multiple Periods
Started24
Completed23
Not completed1
Stimgenics SCS Parameters
Participant flow — Stimgenics SCS Parameters
MilestoneSingle Arm With Multiple Periods
Started23
Completed20
Not completed3

Outcome measures

PrimaryChange 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
Reported as:
Mean · Score on a 11 point scale
Change in Pain Relative to Baseline and After a Trial Period
Score on a 11 point scaleConventional SCSStimgenics SCS
Change in Pain Relative to Baseline and After a Trial Period4.2 ± 2.02.4 ± 1.8

Adverse events

Collected over 1-10 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Conventional SCS0/25 (0%)1/25 (4%)3/25 (12%)
Washout Period0/20 (0%)0/20 (0%)0/20 (0%)
Stimgenics SCS0/20 (0%)0/20 (0%)0/20 (0%)
Most frequent serious events
Most frequent serious events
EventConventional SCSWashout PeriodStimgenics SCS
Epidural abscessInfections and infestations1/250/200/20
Most frequent other events
Most frequent other events
EventConventional SCSWashout PeriodStimgenics SCS
Lead movementSurgical and medical procedures3/250/200/20

Baseline characteristics

Chronic Back Pain Patients

Age, Continuous
Age, Continuous(years)Enrolled Patients
Mean62.4 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Enrolled Patients
Female15
Male10
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Enrolled Patients
Back Pain on Numeric Pain Rating Scale (11-point rating scale)
Back Pain on Numeric Pain Rating Scale (11-point rating scale)(Score on a scale)Enrolled Patients
Mean7.4 ± 1.2
Leg Pain Numeric Pain Rating Scale (11-point rating scale)
Leg Pain Numeric Pain Rating Scale (11-point rating scale)(Score on a scale)Enrolled Patients
Mean4 ± 2.8
08

Study locations

1 site
  • StimGenics
    Bloomington, Illinois 61701, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 24, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03110601
Lead sponsor
Stimgenics LLC
Responsible party
Sponsor
First posted
Apr 12, 2017
Start date
May 5, 2017
Primary completion
Oct 12, 2017
Completion
Oct 12, 2017
Results posted
Apr 16, 2019
Last update
Apr 16, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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