Clinical trial NCT01305525: A Prospective Clinical Outcomes Registry
Official title: Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: SCS
St. Jude Medical
Neuromodulation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients implanted with a neuromodulation system

Brief summary: This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.

Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.


Eligibility criteria: Inclusion Criteria:

1. Patient has signed and received a copy of the Informed Consent form;
2. Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
3. Patient is 18 years of age or older.
4. Patient is not currently participating in another clinical trial.

Exclusion Criteria:

* None

Primary outcomes:
measure: Patient reported outcomes over time
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Azusa
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Bloomfield Hills
country: United States
state: Michigan
city: Waterford
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Kalispell
country: United States
state: Montana
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Mansfield
country: United States
state: Ohio
city: Purcell
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Edmonds
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
city: San Juan
country: Puerto Rico
Study officials:
References: