Chronic Pain
Conditions
Brief summary
Trialing of PM modulation therapy in patients with chronic intractable low back pain
Interventions
DEVICEControl - Conventional SCS
Conventional SCS Parameters
DEVICETest - Stimgenics SCS
Stimgenics SCS Parameters
Sponsors
Stimgenics LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Relative to Baseline and After a Trial Period | Baseline and 4 days plus or minus 1 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
Non-randomized cross-over study in which all eligible participants received the same order of procedures (i.e. Conventional SCS parameters for 4 days, then a washout period of 1 day, then PM-SCS parameters for 4 days).
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients Back pain patients that were trialed with Conventional SCS parameters, then after a washout period the same patients were trialed with PM-SCS parameters (Stimgenics SCS parameters). | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Enrolled Patients | — |
|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 11.5 | — |
| Back Pain on Numeric Pain Rating Scale (11-point rating scale) | 7.4 Score on a scale STANDARD_DEVIATION 1.2 | — |
| Leg Pain Numeric Pain Rating Scale (11-point rating scale) | 4 Score on a scale STANDARD_DEVIATION 2.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 3 / 25 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 25 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
Population: Chronic Back Pain Patients with or without leg pain; 4 subjects experience known adverse events (such as lead migration) that prevented them from testing Stimgenics SCS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional SCS | Change in Pain Relative to Baseline and After a Trial Period | 4.2 Score on a 11 point scale | Standard Deviation 2 |
| Stimgenics SCS | Change in Pain Relative to Baseline and After a Trial Period | 2.4 Score on a 11 point scale | Standard Deviation 1.8 |