Abbott Proclaim 3660 Clinician Manual page 38

Exclusion Criteria
Subjects were excluded if they met any of the following criteria:
Subject was participating in a clinical investigation that included an active treatment arm.
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 Subject had previously been implanted with a neurostimulation system or participated in a
trial period for a neurostimulation system.
Subject had an overall Beck Depression Inventory‡-II (BDI‡
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a score of 3 at the screening visit on question 9, which relates to having suicidal thoughts or
wishes. (Beck Depression Inventory and BDI are trademarks of NCS Pearson, Inc.)
Subject was receiving, applying for, or considering seeking workers compensation or was
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involved in disability litigation.
Subject had an infusion pump or any implantable neurostimulator device.
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Subject had a concurrent, clinically significant or disabling chronic pain problem that
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required additional treatment.
Subject had an existing medical condition, such as epilepsy, stroke, multiple sclerosis,
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acoustic neuroma, or a tumor, that was likely to require repetitive evaluations using magnetic
resonance imaging (MRI).
Subject had a history of cancer requiring active treatment in the last 6 months.
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Subject had an existing medical condition that was likely to require the use of diathermy.
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Subject had pain that originated from peripheral vascular disease.
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Subject had an impaired immune system (immunocompromised).
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Subject had a documented history of an allergic response to titanium or silicone.
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Subject had a documented history of substance abuse (with substances such as narcotics or
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alcohol) or substance dependency within 6 months of the collection of baseline data.
Subject was a female of childbearing potential who was pregnant (confirmed by a positive
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urine or blood pregnancy test).
SUNBURST™ Study Follow-Up Schedule
Subjects who met the aforementioned criteria for participation underwent a conventional SCS trial
using tonic stimulation. Subjects with an unsuccessful SCS trial exited the study following a safety
assessment 2 weeks after the trial. The subjects who remained in the study were implanted with a
permanent system, and then they returned to the office after a recovery period of 2 to 3 weeks (2
weeks minimum) for randomization and system activation. After randomization and activation,
subjects returned to the office for follow-up at 6 and 12 weeks. During the week-12 visit, subjects
crossed over to the alternative stimulation mode. Subjects continued to report to the office at 18
and 24 weeks for follow-up. After the week-24 visit, subjects continued to attend follow-up visits
every 6 months for 2 years or until the study closed, whichever occurred first.
Clinical Endpoints
The primary effectiveness endpoint was a non-inferiority test comparing the change in the VAS
pain diary score during tonic stimulation with the change in VAS pain diary score during burst
stimulation.
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II) score greater than 24 or had
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