A Prospective Clinical Outcomes Registry (PAIN Registry)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305525
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