A Prospective Clinical Outcomes Registry (PAIN Registry)
|ClinicalTrials.gov Identifier: NCT01305525|
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : July 27, 2015
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.
|Condition or disease||Intervention/treatment|
|Pain||Device: St. Jude Medical Spinal Cord Stimulation Systems|
|Study Type :||Observational|
|Actual Enrollment :||614 participants|
|Official Title:||Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
|Spinal Cord Stimulation||
Device: St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation
- Patient reported outcomes over time [ Time Frame: 2 years ]The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305525
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