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

October 7, 2008
March 12, 2013
October 2008
April 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00768872 on ClinicalTrials.gov 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.

Not Provided
Observational
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
Not Provided
April 2012   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768872
1644
No
MedtronicNeuro
MedtronicNeuro
Not Provided
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
MedtronicNeuro
March 2013

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