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

Abbott Medical Devices2 sites in 1 country60 target enrollmentNovember 2016

ConditionsChronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Abbott Medical Devices
Enrollment: 60
Locations: 2
Primary Endpoint: Visual Analog Scale (VAS) for Back Pain at SCS Trial
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

August 19, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) for Back Pain at SCS Trial

Time Frame: 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 Outcomes

Visual Analog Scale (VAS) for Back Pain at 6 Months(6 months after activation of permanent SCS implant)
ODI at 6 Months(6 months after activation of permanent SCS implant)
EQ-5D at SCS Trial(after 2 weeks of SCS trial)
ODI at 3 Months(3 months after activation of permanent SCS implant)
EQ-5D at 6 Month(6 months after activation of permanent SCS implant)
Satisfaction Questionnaire(12 month follow up)
Visual Analog Scale (VAS) for Back Pain at 3 Months(3 months after activation of permanent SCS implant)
ODI at SCS Trial(first SCS trial assessment (up to two weeks after electrodes implantation))
ODI at 12 Months(12 months after activation of permanent SCS implant)
Visual Analog Scale (VAS) for Back Pain at 12 Months(12 months after activation of permanent SCS implant)
EQ-5D at 3 Month(3 months after activation of permanent SCS implant)
EQ-5D at 12 Month(12 months after activation of permanent SCS implant)