Chronic Leg Pain, Chronic Low-back Pain, Chronic Pain, Intractable Pain, Leg Pain, Low Back Pain
Conditions
Keywords
Spinal Cord Stimulation
Brief summary
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.
Interventions
DEVICEBoston Scientific WaveWriter Alpha™ SCS Systems
Time Varied Pulse (TVP)-SCS settings
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Targeted Pain Responder Rate | 3 months post-activation | Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation |
Countries
United States
Contacts
CONTACTThanh Hoang
CONTACTDiane Keesey
STUDY_DIRECTORNatalie M Bloom Lyons
Boston Scientific Corporation
Outcome results
None listed