Spinal Cord Stimulation Research Study (ADR-SCS)

Medtronic

Status: Completed

Conditions: Chronic Low Back and Leg Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT00768872

1644

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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