Spinal Cord Stimulation Research Study

Medtronic

Status: Completed

Conditions: Chronic Low Back and Leg Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT00737581

1648

Details and patient eligibility

About

The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be ambulatory
• Be 18 years of age or older
• Have chronic low back pain and/or leg pain due to neuropathic causes
• Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
• Be implanted with percutaneous thoracic leads
• Have stable pain control
• Adjust stimulation parameters manually on a regular basis
• Be willing and able to complete protocol requirements
• Be willing and able to provide written informed consent
• Be male or nonpregnant female

Exclusion criteria

• Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
• Be morbidly obese
• Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study