Spinal Cord Stimulation Research Study (ADR-SCS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00768872
First received: October 7, 2008
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.


Condition
Chronic Low Back and Leg Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study

Further study details as provided by MedtronicNeuro:

Enrollment: 66
Study Start Date: October 2008
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  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

Candidates for Spinal Cord Stimulation

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Candidate for SCS device trial
  • Subject is ambulatory
  • Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
  • Undergoing treatment for low back pain or low back pain plus leg pain
  • Does not have or has not had a previous SCS implant
  • Willing and able to complete protocol requirements
  • Willing and able to sign the study-specific Informed Consent form
  • Male or non-pregnant female

Exclusion Criteria:

  • Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
  • Cancer or any other malignant disease
  • Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
  • A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
  • Non-English speaking or an inability to complete questionnaires accurately
  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: NCT00768872

Locations
United States, California
Napa Pain Institute
Napa, California, United States, 94558
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, United States, 55435
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: David M Schultz, MD Medical Advanced Pain Specialists (MAPS)
Principal Investigator: Robert Jamison, Ph.D Brigham and Women's Hospital
Principal Investigator: Eric Grigsby, M.D. Napa Pain Institute
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00768872     History of Changes
Other Study ID Numbers: 1644
Study First Received: October 7, 2008
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
activity, spinal cord stimulation, pain

ClinicalTrials.gov processed this record on July 29, 2014