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

STATUS

Recruiting
days left to enroll

55
participants needed

50
sponsor

Abbott Medical Devices

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Updated on 4 March 2022

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opioid

conventional treatment

spinal cord

arm pain

Summary

This is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back

Description

Subjects diagnosed with chronic intractable neck pain with or without radiation down to arm/shoulder/upper back will be considered for inclusion in this study. After baseline evaluation, subjects will undergo a SCS trial using the Abbott Invisible Trial system. At the end of the SCS trial, subjects experiencing at least 50% pain relief, according to average neck VAS (calculated by the average of last 3 days on the pain diary), will be considered for permanent implant and further participation in the study. Pain intensity, quality of life, disability, headache severity, sleep quality, patient satisfaction, anxiety, depression, stimulation sensation and medication usage assessments will be performed at baseline, after SCS trial and at the 3, 6 and 12 month follow up visits.

Details

Condition	Neck Pain, Upper Limb Pain
Treatment	Spinal Cord Stimulation (SCS)
Clinical Study Identifier	NCT03159169
Sponsor	Abbott Medical Devices
Last Modified on	4 March 2022

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Eligibility		Yes	No	Not Sure
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 which may 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 without radiation down to arm/shoulder/upper back
	Subject has neck pain intensity of at least 6.0 cm out of 10.0 cm on the average neck 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 or less for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase 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
	Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, moderate or severe cervical stenosis determined by existing or new MRI scan performed as part of standard of care, mechanical neck pain originating from cervical facet joint syndrome, post-herpetic neuralgia, 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 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 1 year
	Subject is involved in an injury claim under current litigation

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