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

Not Applicable

Completed

Conditions: Chronic Pain

Interventions: Device: Anatomical midline lead evaluation first
Device: Paresthesia mapping lead evaluation first

Registration Number: NCT02986074

Lead Sponsor: Abbott Medical Devices

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 Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subject is able to provide informed consent to participate in the study;
Subject is 18 years of age or older;
Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy as per NICE Tag 0159;
FBSS subjects with predominant low back pain;
Subject has a lower back pain intensity of at least 6.0 out of 10.0 on the VAS at baseline;
Subject is on stable pain medications with a total opioid equivalent of 120 mgs a day or less for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device;
Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study

Exclusion Criteria

Subjects with significant scoliosis even if surgically corrected
Subject is currently participating in a clinical investigation that includes an active treatment arm;
Subject has been implanted with or participated in a trial period for a neurostimulation system;
Subject has an infusion pump;
Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus;
Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
Subject is immunocompromised;
Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
Subject has history of cancer requiring active treatment in the last 12 months;
Subject has an existing medical condition that is likely to require the use of diathermy in the future;
Subject has documented history of allergic response to titanium or silicone;
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anatomical midline lead first	Anatomical midline lead evaluation first	subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead
Paresthesia mapping lead first	Paresthesia mapping lead evaluation first	subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Back Pain at SCS Trial	after 2 weeks of SCS trial	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Back Pain at 6 Months	6 months after activation of permanent SCS implant	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
ODI at 6 Months	6 months after activation of permanent SCS implant	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
EQ-5D at SCS Trial	after 2 weeks of 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)
ODI at 3 Months	3 months after activation of permanent SCS implant	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
EQ-5D at 6 Month	6 months after activation of permanent SCS implant	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)
Satisfaction Questionnaire	12 month follow up	questionnaire regarding patient satisfaction with the therapy
Visual Analog Scale (VAS) for Back Pain at 3 Months	3 months after activation of permanent SCS implant	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
ODI at SCS Trial	first SCS trial assessment (up to two weeks after electrodes implantation)	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
ODI at 12 Months	12 months after activation of permanent SCS implant	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Visual Analog Scale (VAS) for Back Pain at 12 Months	12 months after activation of permanent SCS implant	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
EQ-5D at 3 Month	3 months after activation of permanent SCS implant	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)
EQ-5D at 12 Month	12 months after activation of permanent SCS implant	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)