Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC)

Boston Scientific

Status

Enrolling

Conditions

Chronic Low-back Pain

Leg Pain

Intractable Pain

Chronic Pain

Chronic Leg Pain

Low Back Pain

Treatments

Device: Boston Scientific WaveWriter Alpha™ SCS Systems

Study type

Interventional

Funder types

Industry

Identifiers

NCT07190807

A4116

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.