A Prospective Clinical Outcomes Registry (PAIN Registry)

January 28, 2019 updated by: Abbott Medical Devices

Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

614

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Azusa, California, United States
      • Chula Vista, California, United States
      • Sacramento, California, United States
    • Florida
      • Jacksonville, Florida, United States
      • Tampa, Florida, United States
    • Indiana
      • Evansville, Indiana, United States
      • Muncie, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Michigan
      • Bloomfield Hills, Michigan, United States
      • Waterford, Michigan, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • Montana
      • Kalispell, Montana, United States
    • New York
      • New York, New York, United States
      • Syracuse, New York, United States
      • Utica, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Mansfield, Ohio, United States
    • Oklahoma
      • Purcell, Oklahoma, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
    • Texas
      • Houston, Texas, United States
      • Southlake, Texas, United States
      • Webster, Texas, United States
    • Virginia
      • Arlington, Virginia, United States
    • Washington
      • Edmonds, Washington, United States
      • Kirkland, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
      • Morgantown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients implanted with a neuromodulation system

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal Cord Stimulation
Device: St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (Estimate)

February 28, 2011

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C-09-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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