Clinical Trial: CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

Brief Summary: The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.

Detailed Summary: The primary purpose of this study is to compare the therapeutic efficacy of the conventional, paresthesia mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more novel, anatomic midline-based approach that has the potential to streamline the workflow associated with the SCS treatment continuum.
Sponsor: St. Jude Medical

Current Primary Outcome: Change in relief of pain as measured using Visual Analog Scale (VAS) for pain between the first and second SCS trial assessments [ Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation) and second SCS trial assessment (up to two weeks after the first trial assessment) ]

Subjective evaluation of pain levels routinely used in clinical practice


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Visual Analog Scale (VAS) for pain at 3 months [ Time Frame: 3 months after activation of permanent SCS implant ]
    Subjective evaluation of pain levels routinely used in clinical practice
  • Change from baseline in Visual Analog Scale (VAS) for pain at 6 months [ Time Frame: 6 months after activation of permanent SCS implant ]
    Subjective evaluation of pain levels routinely used in clinical practice
  • Change from baseline in Visual Analog Scale (VAS) for pain at 12 months [ Time Frame: 12 months after activation of permanent SCS implant ]
    Subjective evaluation of pain levels routinely used in clinical practice
  • Change from baseline in EQ-5D at SCS trial assessment 1 [ Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation) ]
    questionnaire regarding quality of life
  • Change from baseline in EQ-5D at SCS trial assessment 2 [ Time Frame: second SCS trial assessment (up to two weeks after first SCS trial assessment) ]
    questionnaire regarding quality of life
  • Change from baseline in EQ-5D at 3 month [ Time Frame: 3 months after activation of permanent SCS implant ]
    questionnaire regarding quality of life
  • Change from baseline in EQ-5D at 6 month [ Time Frame: 6 months after activation of permanent SCS implant ]
    questionnaire regarding quality of life
  • Change from baseline in EQ-5D at 12 month [ Time Frame: 12 months after activation of permanent SCS implant ]
    questionnaire regarding quality of life
  • Change from baseline in ODI at SCS trial assessment 1 [ Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation) ]
    questionnaire regarding disability level
  • Change from baseline in ODI at SCS trial assessment 2 [ Time Frame: second SCS trial assessment (up to two weeks after first SCS trial assessment) ]
    questionnaire regarding disability level
  • Change from baseline in ODI at SCS 3 months [ Time Frame: 3 months after activation of permanent SCS implant ]
    questionnaire regarding disability level
  • Change from baseline in ODI at SCS 6 months [ Time Frame: 6 months after activation of permanent SCS implant ]
    questionnaire regarding disability level
  • Change from baseline in ODI at SCS 12 months [ Time Frame: 12 months after activation of permanent SCS implant ]
    questionnaire regarding disability level
  • Satisfaction [ Time Frame: 3 month follow up ]
    questionnaire regarding patient satisfaction with the therapy
  • Satisfaction [ Time Frame: 6 month follow up ]
    questionnaire regarding patient satisfaction with the therapy
  • Satisfaction [ Time Frame: 12 month follow up ]
    questionnaire regarding patient satisfaction with the therapy


Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: December 2, 2016
Date Started: November 2016
Date Completion: September 2018
Last Updated: May 16, 2017
Last Verified: May 2017