Study of PM Modulation Therapy in Trial Phase

Study Overview
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Brief Summary
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Trialing of PM modulation therapy in patients with chronic intractable low back pain

Official Title
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Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Control - Conventional SCS
* Device: Test - Stimgenics SCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Must be older than 18 years old. Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS). Appropriate candidate for spinal cord stimulation trial. Subjects must be on a stable dose of pain medication regimen for at least 1 month. 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. Must be able to comply with the requirement of study visits and follow-up and phone visits. Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians. Exclusion Criteria: Systemic infection. Any active implanted device. Previous experience with SCS therapy either during a trial or fully implanted Evidence of serious neurological, psychological or psychiatric disorders. Mechanical spinal instability. Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests. Human immunodeficiency virus (HIV) infection or a clinically significant infection. 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. 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. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension. Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders. 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. 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. Concurrent participation in another clinical study. Involvement in an injury claim under current litigation or a pending or approved workers' compensation claim.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control - Conventional SCS<br>Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator. | Device: Control - Conventional SCS<br>* Conventional SCS Parameters<br>|
| No Intervention: Washout Period<br>1 day where no stimulation is provided | |
| Experimental: Test - Stimgenics SCS<br>Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator. | Device: Test - Stimgenics SCS<br>* Stimgenics SCS Parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 4 days plus or minus 1 days |