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
Updated on 4 March 2022
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 IdentifierNCT03159169
SponsorAbbott Medical Devices
Last Modified on4 March 2022

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note