Precision Retrospective Outcomes (PRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01550575
First received: March 5, 2012
Last updated: November 12, 2013
Last verified: November 2013
  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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01550575

Contacts
Contact: Diane Bowers (661) 949-4175 Diane.Bowers@bsci.com
Contact: Nitzan Mekel-Bobrov, PhD 661-949-4537 Nitzan.Mekel-Bobrov@bsci.com

Locations
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Wendy Flake    252-209-3205    wendy.flake@vidanthealth.com   
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01550575     History of Changes
Other Study ID Numbers: A7005
Study First Received: March 5, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014