SCS
Conditions
Brief summary
The objective is to provide information to help the physician community decide the most effective type of device/therapy that would work for their patients, based off of the etiology of pain, the location of the pain for sustained pain relief.
Detailed description
This registry will enroll patients that qualify for an SCS implant, for approved pain areas, as defined by medicare guidelines, and follow these patients for up to 12 months for denovo implants. For patients who have lost their pain relief over time, with a prior implanted device, this registry will follow a change out to another vendor/therapy, and follow those patients for up to 12 months.
Interventions
DEVICESCS
Conventional SCS implants approved through all payors(government and private) for FDA approved indications
Sponsors
Cardio Surgical Partners
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain relief | 12 months | Percent of patient who show a change in Pain Scale (PIPS) \>50% at the end of follow up period of 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sustained change of pain over the follow up period | 12 months | Sustained Percentage change in Pain Scale (PIPS)\>50% for the 12 month follow up period. |
Countries
United States
Contacts
Primary Contacttom Gordon
Outcome results
None listed