BurstDR™ micrOdosing stimuLation in De-novo Patients

Not Applicable

Completed

Conditions: Pain, Intractable
Pain, Back

Interventions: Device: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

Registration Number: NCT03350256

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.

Detailed Description: Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.

In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subject is able to provide informed consent to participate in the study;
Subject diagnosed with chronic intractable pain associated with back and/or limbs;
Subject is 18 years of age or older;
Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;
Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;
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 on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit;
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

Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;

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 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;
Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);
Subject has life expectancy of less than 6 months;
Subject is involved in an injury claim under current litigation

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microdosing group	Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.	Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation	baseline and 1 week after trial lead implant (trial stimulation)	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1	Baseline and 1 month follow up visit	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3	Baseline and 6 month follow up visit	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2	Baseline and 3 month follow up visit	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Change in Disability Index Between Baseline and and Follow up 3	Baseline and 6 month follow up visit	questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Change in Quality of Life Between Baseline and Trial Stimulation	Baseline and 1 week after trial lead implant (trial stimulation)	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)
Change in Quality of Life Between Baseline and Follow up 1	Baseline and 1 month follow up visit	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)
Change in Disability Index Between Baseline and Trial Stimulation	Baseline and 1 week after trial lead implant (trial stimulation)	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Change in Disability Index Between Baseline and and Follow up 1	Baseline and 1 month follow up visit	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Change in Quality of Life Between Baseline and Follow up 2	Baseline and 3 month follow up visit	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)
Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation	Baseline and 1 week after trial lead implant (trial stimulation)	Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Change in Quality of Life Between Baseline and Follow up 3	Baseline and 6 month follow up visit	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)
Change in Disability Index Between Baseline and and Follow up 2	Baseline and 3 month follow up visit	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Change in Pain Catastrophizing Scale Between Baseline and Follow up 1	Baseline and 1 month follow up visit	Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Change in Pain Catastrophizing Scale Between Baseline and Follow up 2	Baseline and 3 month follow up visit	Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Change in Pain Catastrophizing Scale Between Baseline and Follow up 3	Baseline and 6 month follow up visit	Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)

Trial Locations

Locations (5): Thrive Clinic
🇺🇸
Santa Rosa, California, United States
Ambulatory Surgery Center of Killeen
🇺🇸
Killeen, Texas, United States
Nevada advanced pain specialists
🇺🇸
Reno, Nevada, United States
OnSite Clinical Solutions
🇺🇸
Asheville, North Carolina, United States
Premier Pain Solutions
🇺🇸
Charleston, West Virginia, United States