Clinical Trial: A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the A

Brief Summary: 12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.

Detailed Summary:
Sponsor: St. Jude Medical

Current Primary Outcome:

• Specificity of Stimulation Induced Paresthesia [ Time Frame: 3 Months post implantation ]
  A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia
• Stability of Stimulation Induced Paresthesia [ Time Frame: 3 Months post implantation ]
  A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position
• Patient Interactions with System [ Time Frame: 3 Months post implantation ]
  A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: September 9, 2014
Date Started: September 2014
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017