A Prospective Clinical Outcomes Registry (PAIN Registry)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry|
- Patient reported outcomes over time [ Time Frame: 2 years ] [ Designated as safety issue: No ]The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
|Study Start Date:||June 2009|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Spinal Cord Stimulation||
Device: St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305525
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