Clinical trial NCT02986074: CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
Official title: CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: St Thomas
name: Seacroft Hospital
First posted: 2016-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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;
* 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).

Primary outcomes:
measure: Visual Analog Scale (VAS) for Back Pain at SCS Trial
timeFrame: after 2 weeks of SCS trial
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Back Pain at 3 Months
timeFrame: 3 months after activation of permanent SCS implant
measure: Visual Analog Scale (VAS) for Back Pain at 6 Months
timeFrame: 6 months after activation of permanent SCS implant
measure: Visual Analog Scale (VAS) for Back Pain at 12 Months
timeFrame: 12 months after activation of permanent SCS implant
measure: EQ-5D at SCS Trial
timeFrame: after 2 weeks of SCS trial
measure: EQ-5D at 3 Month
timeFrame: 3 months after activation of permanent SCS implant
measure: EQ-5D at 6 Month
timeFrame: 6 months after activation of permanent SCS implant
measure: EQ-5D at 12 Month
timeFrame: 12 months after activation of permanent SCS implant
measure: ODI at SCS Trial
timeFrame: first SCS trial assessment (up to two weeks after electrodes implantation)
measure: ODI at 3 Months
timeFrame: 3 months after activation of permanent SCS implant
measure: ODI at 6 Months
timeFrame: 6 months after activation of permanent SCS implant
measure: ODI at 12 Months
timeFrame: 12 months after activation of permanent SCS implant
measure: Satisfaction Questionnaire
timeFrame: 3 month follow up
measure: Satisfaction Questionnaire
timeFrame: 6 month follow up
measure: Satisfaction Questionnaire
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
state: Yorkshire And The Humber
city: London
country: United Kingdom
facility: St. Thomas Hospital
Study officials:
affiliation: Abbott Medical Devices
name: Lalit Venkatesan, Ph.D.
role: STUDY_DIRECTOR
References: