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

MedtronicNeuro3 sites in 1 country66 target enrollmentOctober 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Low Back and Leg Pain
Sponsor: MedtronicNeuro
Enrollment: 66
Locations: 3
Primary Endpoint: Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)
Status: Completed
Last Updated: 9 years ago

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

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

March 2013

Last Updated

9 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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