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Precision Retrospective Outcomes (PRO)

This study is currently recruiting participants.
Verified February 2017 by Boston Scientific Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550575
First Posted: March 12, 2012
Last Update Posted: February 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
This study will evaluate deidentified (anonymous) data in subject medical charts to review the clinical outcomes of spinal cord stimulation.

Condition Intervention
Chronic Pain Device: Non Boston Scientific spinal cord stimulation system Device: Boston Scientific Precision Plus spinal cord stimulation system Other: Non-spinal cord stimulation conventional medical management for chronic pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Precision Retrospective Outcomes

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Estimated Enrollment: 2000
Study Start Date: March 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SCS-Eligible Patients
Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system
Device: Non Boston Scientific spinal cord stimulation system
Epidural spinal cord stimulation
Device: Boston Scientific Precision Plus spinal cord stimulation system
epidural spinal cord stimulation
Other: Non-spinal cord stimulation conventional medical management for chronic pain
May include chronic pain medication, interventional pain procedures, spine surgery, etc.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have previously been implanted with , or who are candidates for implantation with a spinal cord stimulation system.
Criteria

Inclusion Criteria:

  • Previously treated with or eligible for implantation with a spinal cord stimulation system
  • 18 years of age or older at the start of Baseline
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01550575


Contacts
Contact: Diane Bowers (661) 949-4175 Diane.Bowers@bsci.com

Locations
United States, California
Boston Scientific Clinical Research Information - Toll Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01550575     History of Changes
Other Study ID Numbers: A7005
Lumina Study Cohort series ( Other Identifier: Boston Scientific Corporation )
First Submitted: March 5, 2012
First Posted: March 12, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms