A Prospective Clinical Outcomes Registry (PAIN Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier:
NCT01305525
First received: February 25, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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 Intervention
Pain
Device: St. Jude Medical Spinal Cord Stimulation Systems

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry

Further study details as provided by Advanced Neuromodulation Systems:

Primary Outcome Measures:
  • 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.


Enrollment: 614
Study Start Date: June 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spinal Cord Stimulation Device: St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients implanted with a neuromodulation system

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305525

  Show 32 Study Locations
Sponsors and Collaborators
Advanced Neuromodulation Systems
  More Information

No publications provided

Responsible Party: Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier: NCT01305525     History of Changes
Other Study ID Numbers: C-09-01
Study First Received: February 25, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Advanced Neuromodulation Systems:
SCS
St. Jude Medical
Neuromodulation

ClinicalTrials.gov processed this record on September 30, 2014