Spinal Cord Stimulation Research Study

Completed

• Conditions: Chronic Low Back and Leg Pain

• Registration Number: NCT00737581
• Lead Sponsor: MedtronicNeuro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Medical Advanced Pain Specialists (MAPS); 🇺🇸 Edina, Minnesota, United States

Center for Pain Control; 🇺🇸 Garland, Texas, United States