Spinal Cord Stimulation Research Study - Full Text View

Spinal Cord Stimulation Research Study (ADR-SCS)

This study is currently recruiting participants.

Verified by MedtronicNeuro, December 2008

First Received: October 7, 2008 Last Updated: December 29, 2008 History of Changes

Sponsored by:	MedtronicNeuro
Information provided by:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00768872

Purpose

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

Condition
Chronic Low Back and Leg Pain

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study

Further study details as provided by MedtronicNeuro:

Estimated Enrollment:	33
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768872

Contacts

Contact: Christa Nichols	952-974-4370	cnichols@painphysicians.com
Contact: Caroline Holcomb	617-732-9462	cholcomb@partners.org

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Caroline Holcomb 617-732-9462 cholcomb@partners.org
United States, Minnesota
Medical Advanced Pain Specialists (MAPS)	Recruiting
Edina, Minnesota, United States, 55435
Contact: Christa Nichols 952-974-4370 ext 234

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

More Information

No publications provided

Responsible Party:	Medtronic, Inc. ( Medtronic Neuromodulation )
Study ID Numbers:	1644
Study First Received:	October 7, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00768872 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by MedtronicNeuro:

activity, spinal cord stimulation, pain

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on May 07, 2009