Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Summit Surgery Center | Reno | Nevada | United States | 89511 |
Sponsors and Collaborators
- Cardio Surgical Partners
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PainReg