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Precision Retrospective Outcomes (PRO)

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ClinicalTrials.gov Identifier: NCT01550575
Recruitment Status : Recruiting
First Posted : March 12, 2012
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
This study will evaluate deidentified (anonymous) data in subject medical charts to review the clinical outcomes of spinal cord stimulation.

Condition or disease Intervention/treatment
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
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Precision Retrospective Outcomes
Study Start Date : March 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
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.





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: March 12, 2012    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

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