The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial
Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial
Seacroft Hospital
Leeds, Yorkshire and the Humber, United Kingdom
St. Thomas Hospital
London, United Kingdom
Visual Analog Scale (VAS) for Back Pain at SCS Trial
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: after 2 weeks of SCS trial
Visual Analog Scale (VAS) for Back Pain at 3 Months
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: 3 months after activation of permanent SCS implant
Visual Analog Scale (VAS) for Back Pain at 6 Months
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: 6 months after activation of permanent SCS implant
Visual Analog Scale (VAS) for Back Pain at 12 Months
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: 12 months after activation of permanent SCS implant
EQ-5D at SCS Trial
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: after 2 weeks of SCS trial
EQ-5D at 3 Month
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: 3 months after activation of permanent SCS implant
EQ-5D at 6 Month
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Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: 6 months after activation of permanent SCS implant
EQ-5D at 12 Month
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: 12 months after activation of permanent SCS implant
ODI at SCS Trial
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: first SCS trial assessment (up to two weeks after electrodes implantation)
ODI at 3 Months
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: 3 months after activation of permanent SCS implant
ODI at 6 Months
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: 6 months after activation of permanent SCS implant
ODI at 12 Months
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: 12 months after activation of permanent SCS implant
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Time frame: 3 month follow up
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Time frame: 6 month follow up
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Time frame: 12 month follow up