Treatment of Neck and Upper Limb Pain Using BurstDR (De Ridder) Stimulation

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 whichmay include pharmacological treatment, physical therapy, and injections;

• Subject has failed to respond to medial branch blocks;

• Subject diagnosed with chronic predominant intractable neck pain with or withoutradiation down to arm/shoulder/upper back;

• Subject has neck pain intensity of at least 6.0 cm out of 10.0 cm on the averageneck pain VAS at baseline (according to the last 3 days of the baseline pain diary);

• Subject is on stable pain medications with a total opioid equivalent of120 mg orless for at least 28 days prior to enrolling in this study, and is willing to stayon those medications with no dose increase until activation of the permanentlyimplanted SCS device;

• Subject's medical record has been evaluated by the Investigator to ensure that thesubject is a good candidate for a neurostimulation system;

• Subject is willing to cooperate with the study requirements including compliancewith the regimen and completion of all office visits;

• Female candidates of child-bearing potential agree to commit to the use of aneffective method of contraception (including but not limited to sterilization,barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythmmethod, 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, moderate or severe cervical stenosisdetermined by existing or new MRI scan performed as part of standard of care,mechanical neck pain originating from cervical facet joint syndrome, post-herpeticneuralgia, spondylolisthesis, retrolisthesis, CRPS (Chronic Regional Pain Syndrome)or uncontrolled diabetes mellitus;

• Subject with significant scoliosis even if surgically corrected;

• Subject is currently participating in a clinical investigation that includes anactive treatment arm;

• Subject has been implanted with or participated in a trial period for aneurostimulation system;

• Subject has an infusion pump;

• Subject has evidence of an active disruptive psychological or psychiatric disorderas determined as per standard of care;

• Subject has a current diagnosis of a progressive neurological disease as determinedby the Investigator;

• Subject is immunocompromised;

• Subject has an existing medical condition that is likely to require repetitive MRIevaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acousticneuroma, 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 ofdiathermy 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.) orsubstance 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 1 year;

• Subject is involved in an injury claim under current litigation