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

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ClinicalTrials.gov Identifier: NCT03159169
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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

Condition or disease Intervention/treatment Phase
Neck Pain Upper Limb Pain Device: Spinal Cord Stimulation (SCS) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Neck and Upper (NU) Limb Pain Using BurstDR Stimulation
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study patients
Single arm study. Patients will receive Spinal Cord Stimulation (SCS) according to standard clinical procedures.
Device: Spinal Cord Stimulation (SCS)
Implantation of SCS electrodes and stimulator according to clinical standards




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) for pain [ Time Frame: baseline ]
    Golden standard self-evaluation of pain intensity

  2. Visual Analog Scale for pain [ Time Frame: end of SCS trial (up to two weeks after electrodes implantation) ]
    Golden standard self-evaluation of pain intensity

  3. Visual Analog Scale for pain [ Time Frame: 3 months post permanent implant ]
    Golden standard self-evaluation of pain intensity

  4. Visual Analog Scale for pain [ Time Frame: 6 months post permanent implant ]
    Golden standard self-evaluation of pain intensity

  5. Visual Analog Scale for pain [ Time Frame: 12 months post permanent implant ]
    Golden standard self-evaluation of pain intensity


Secondary Outcome Measures :
  1. EQ-5D - 5L (European Quality of Life) (5D-dimensions); (5L levels) [ Time Frame: baseline ]
    Self reported questionnaire on quality of life

  2. EQ-5D - 5L [ Time Frame: End of SCS trial (up to two weeks after electrodes implantation) ]
    Self reported questionnaire on quality of life

  3. EQ-5D - 5L [ Time Frame: 3 months post permanent implant ]
    Self reported questionnaire on quality of life

  4. EQ-5D - 5L [ Time Frame: 6 months post permanent implant ]
    Self reported questionnaire on quality of life

  5. EQ-5D - 5L [ Time Frame: 12 months post permanent implant ]
    Self reported questionnaire on quality of life

  6. ONDI [ Time Frame: baseline ]
    Disability questionnaire

  7. ONDI (Oswestry neck disability index) [ Time Frame: end of SCS trial (up to two weeks after electrodes implantation) ]
    Disability questionnaire

  8. ONDI [ Time Frame: 3 months post permanent implant ]
    Disability questionnaire

  9. ONDI [ Time Frame: 6 months post permanent implant ]
    Disability questionnaire

  10. ONDI [ Time Frame: 12 months post permanent implant ]
    Disability questionnaire

  11. Patient Global Impression of Change [ Time Frame: end of SCS trial (up to two weeks after electrodes implantation) ]
    questionnaire on patient satisfaction with therapeutic outcome

  12. Patient Global Impression of Change [ Time Frame: 3 months post permanent implant ]
    questionnaire on patient satisfaction with therapeutic outcome

  13. Patient Global Impression of Change [ Time Frame: 6 months post permanent implant ]
    questionnaire on patient satisfaction with therapeutic outcome

  14. Patient Global Impression of Change [ Time Frame: 12 months post permanent implant ]
    questionnaire on patient satisfaction with therapeutic outcome

  15. Headache Impact Test [ Time Frame: baseline ]
    Questionnaire on headache burden

  16. Headache Impact Test [ Time Frame: end of SCS trial (up to two weeks after electrodes implantation) ]
    Questionnaire on headache burden

  17. Headache Impact Test [ Time Frame: 3 months post permanent implant ]
    Questionnaire on headache burden

  18. Headache Impact Test [ Time Frame: 6 months post permanent implant ]
    Questionnaire on headache burden

  19. Headache Impact Test [ Time Frame: 12 months post permanent implant ]
    Questionnaire on headache burden

  20. Hospital Anxiety and Depression [ Time Frame: baseline ]
    Questionnaire on anxiety and depression

  21. Hospital Anxiety and Depression [ Time Frame: end of SCS trial (up to two weeks after electrodes implantation) ]
    Questionnaire on anxiety and depression

  22. Hospital Anxiety and Depression [ Time Frame: 3 months post permanent implant ]
    Questionnaire on anxiety and depression

  23. Hospital Anxiety and Depression [ Time Frame: 6 months post permanent implant ]
    Questionnaire on anxiety and depression

  24. Hospital Anxiety and Depression [ Time Frame: 12 months post permanent implant ]
    Questionnaire on anxiety and depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159169


Contacts
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Contact: Lalit Venkatesan, Ph.D. +19723098522 LVenkatesan@sjm.com
Contact: Filippo Agnesi, Ph.D. +19725264860 FAgnesi@sjm.com

Locations
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United Kingdom
Southmead hospital Recruiting
Bristol, United Kingdom
Contact: Ann Rich       Ann.Rich@nbt.nhs.uk   
Principal Investigator: Nik Patel, MD         
Sub-Investigator: Sarah Love-Jones, MD         
Guy's St. Thomas Hospital Recruiting
London, United Kingdom
Contact: Samuel Wesley    02071 883237    Samuel.Wesley@gstt.nhs.uk   
Principal Investigator: Adnan Al-Kaisy, MD         
Sub-Investigator: Stefano Palmisani, MD         
Sub-Investigator: David Pang, MD         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom
Contact: Michelle Beveridge       Michelle.Beveridge@uhs.nhs.uk   
Principal Investigator: Girish Vajramani, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Adnan Al-Kaisy, MD Guy's St. Thomas

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03159169     History of Changes
Other Study ID Numbers: SJM-CIP-10194
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Abbott Medical Devices:
Neck Pain
Upper Limb Pain

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms