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Spinal Cord Stimulation Research Study (ADR-SCS)

This study has been completed.
Information provided by (Responsible Party):
MedtronicNeuro Identifier:
First received: October 7, 2008
Last updated: October 13, 2016
Last verified: October 2016
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.

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:

Primary Outcome Measures:
  • Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds) [ Time Frame: 4, 12, 24 weeks post implant ] [ Designated as safety issue: No ]
  • Change from Baseline in Posture Parameters (minutes per 24 hours) [ Time Frame: 4, 12, 24 weeks post implant ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: October 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Candidates for Spinal Cord Stimulation

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 identifier: NCT00768872

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
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

Responsible Party: MedtronicNeuro Identifier: NCT00768872     History of Changes
Other Study ID Numbers: 1644 
Study First Received: October 7, 2008
Last Updated: October 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
activity, spinal cord stimulation, pain processed this record on October 21, 2016