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Spinal Cord Stimulation Research Study (ADR-SCS)

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ClinicalTrials.gov Identifier: NCT00768872
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Chronic Low Back and Leg Pain

Study Design

Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study
Study Start Date : October 2008
Primary Completion Date : March 2013
Study Completion Date : March 2013
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds) [ Time Frame: 4, 12, 24 weeks post implant ]
  2. Change from Baseline in Posture Parameters (minutes per 24 hours) [ Time Frame: 4, 12, 24 weeks post implant ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00768872     History of Changes
Other Study ID Numbers: 1644
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

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