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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2008

Last Updated Date

March 12, 2013

Start Date ^ICMJE

October 2008

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00768872 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Spinal Cord Stimulation Research Study

Official Title ^ICMJE

Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Candidates for Spinal Cord Stimulation

Condition ^ICMJE

Chronic Low Back and Leg Pain

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00768872

Other Study ID Numbers ^ICMJE

1644

Has Data Monitoring Committee

Responsible Party

MedtronicNeuro

Study Sponsor ^ICMJE

MedtronicNeuro

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

MedtronicNeuro

Verification Date

March 2013

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

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