Dysautonomia International

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)