Study of PM Modulation Therapy in Trial Phase
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control - Conventional SCS
Test - Stimgenics SCS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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.
Sites / Locations
- StimGenics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
Experimental
Arm Label
Control - Conventional SCS
Washout Period
Test - Stimgenics SCS
Arm Description
Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
1 day where no stimulation is provided
Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03110601
Brief Title
Study of PM Modulation Therapy in Trial Phase
Official Title
Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
October 12, 2017 (Actual)
Study Completion Date
October 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stimgenics LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
Trialing of PM modulation therapy in patients with chronic intractable low back pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - Conventional SCS
Arm Type
Active Comparator
Arm Description
Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Arm Title
Washout Period
Arm Type
No Intervention
Arm Description
1 day where no stimulation is provided
Arm Title
Test - Stimgenics SCS
Arm Type
Experimental
Arm Description
Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Intervention Type
Device
Intervention Name(s)
Control - Conventional SCS
Intervention Description
Conventional SCS Parameters
Intervention Type
Device
Intervention Name(s)
Test - Stimgenics SCS
Intervention Description
Stimgenics SCS Parameters
Primary Outcome Measure Information:
Title
Change in Pain Relative to Baseline and After a Trial Period
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
StimGenics
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
12. IPD Sharing Statement
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Study of PM Modulation Therapy in Trial Phase
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