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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

October 7, 2008
October 13, 2016
October 2008
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
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Complete list of historical versions of study NCT00768872 on Archive Site
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Spinal Cord Stimulation Research Study
Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
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Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Candidates for Spinal Cord Stimulation
Chronic Low Back and Leg Pain
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
March 2013   (final data collection date for primary outcome measure)

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
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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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
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP