Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Purpose
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
Conditions
- Chronic Pain
- Intractable Pain
- Low Back Pain
- Chronic Low-back Pain
- Chronic Leg Pain
- Leg Pain
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis. - Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months. - 18 years of age or older when written informed consent is obtained - Able to independently read and complete all questionnaires and assessments provided in English. - Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.
Exclusion Criteria
- Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim). - Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study - A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception. - Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Time Varied Pulse (TVP)-SCS settings |
|
Recruiting Locations
Denver Back Pain Specialists
Greenwood 5423901, Colorado 5417618 80111
Greenwood 5423901, Colorado 5417618 80111
Fox Chase Pain Management
Trevose 5216000, Pennsylvania 6254927 19053
Trevose 5216000, Pennsylvania 6254927 19053
PCPMG Clinical Research Unit, LLC
Greenville 4580543, South Carolina 4597040 29601
Greenville 4580543, South Carolina 4597040 29601
Institute of Precision Pain Medicine
Corpus Christi 4683416, Texas 4736286 78414
Corpus Christi 4683416, Texas 4736286 78414
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation