Clinical Trial: Spinal Cord Stimulation (SCS) Therapy Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Spinal Cord Stimulation (SCS) Therapy Study

Brief Summary: The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.

Detailed Summary:
Sponsor: MedtronicNeuro

Current Primary Outcome: Numeric Pain Rating Scale - Leg pain [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Brief Pain Inventory - Pain severity [ Time Frame: 12 weeks ]
  • Brief Pain Inventory - Pain interference [ Time Frame: 12 weeks ]
  • Quantitative Sensory Testing - Vibration threshold [ Time Frame: 12 weeks ]
  • Quantitative Sensory Testing - Electrical stimuli tolerance [ Time Frame: 12 weeks ]
  • Numeric Pain Rating Scale - Back pain [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: MedtronicNeuro

Dates:
Date Received: February 19, 2015
Date Started: June 2015
Date Completion: January 2017
Last Updated: July 9, 2015
Last Verified: July 2015