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

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

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

Study Overview

• Status: Recruiting
• Conditions: Neck Pain; Upper Limb Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation (SCS)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lalit Venkatesan, Ph.D.; Phone Number: +19723098522; Email: LVenkatesan@sjm.com
• Study Contact Backup: Name: Filippo Agnesi, Ph.D.; Phone Number: +19725264860; Email: FAgnesi@sjm.com

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • Recruiting
    • Southmead Hospital
    • Contact: Ann Rich; Email: Ann.Rich@nbt.nhs.uk
    • Principal Investigator: Nik Patel, MD
    • Sub-Investigator: Sarah Love-Jones, MD
  • London, United Kingdom
    • Recruiting
    • Guy's St. Thomas Hospital
    • Contact: Samuel Wesley; Phone Number: 02071 883237; Email: Samuel.Wesley@gstt.nhs.uk
    • Principal Investigator: Adnan Al-Kaisy, MD
    • Sub-Investigator: Stefano Palmisani, MD
    • Sub-Investigator: David Pang, MD
  • Southampton, United Kingdom
    • Recruiting
    • University Hospital Southampton NHS Foundation Trust
    • Principal Investigator: Girish Vajramani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for pain	Golden standard self-evaluation of pain intensity	baseline
Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	end of SCS trial (up to two weeks after electrodes implantation)
Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	3 months post permanent implant
Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	6 months post permanent implant
Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	12 months post permanent implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D - 5L (European Quality of Life) (5D-dimensions); (5L levels)	Self reported questionnaire on quality of life	baseline
EQ-5D - 5L	Self reported questionnaire on quality of life	End of SCS trial (up to two weeks after electrodes implantation)
EQ-5D - 5L	Self reported questionnaire on quality of life	3 months post permanent implant
EQ-5D - 5L	Self reported questionnaire on quality of life	6 months post permanent implant
EQ-5D - 5L	Self reported questionnaire on quality of life	12 months post permanent implant
ONDI	Disability questionnaire	baseline
ONDI (Oswestry neck disability index)	Disability questionnaire	end of SCS trial (up to two weeks after electrodes implantation)
ONDI	Disability questionnaire	3 months post permanent implant
ONDI	Disability questionnaire	6 months post permanent implant
ONDI	Disability questionnaire	12 months post permanent implant
Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	end of SCS trial (up to two weeks after electrodes implantation)
Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	3 months post permanent implant
Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	6 months post permanent implant
Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	12 months post permanent implant
Headache Impact Test	Questionnaire on headache burden	baseline
Headache Impact Test	Questionnaire on headache burden	end of SCS trial (up to two weeks after electrodes implantation)
Headache Impact Test	Questionnaire on headache burden	3 months post permanent implant
Headache Impact Test	Questionnaire on headache burden	6 months post permanent implant
Headache Impact Test	Questionnaire on headache burden	12 months post permanent implant
Hospital Anxiety and Depression	Questionnaire on anxiety and depression	baseline
Hospital Anxiety and Depression	Questionnaire on anxiety and depression	end of SCS trial (up to two weeks after electrodes implantation)
Hospital Anxiety and Depression	Questionnaire on anxiety and depression	3 months post permanent implant
Hospital Anxiety and Depression	Questionnaire on anxiety and depression	6 months post permanent implant
Hospital Anxiety and Depression	Questionnaire on anxiety and depression	12 months post permanent implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Adnan Al-Kaisy, MD, Guy's St. Thomas

Publications and helpful links

General Publications

• Al-Kaisy A, Vajramani G, Love-Jones S, Patel NK, Royds J, Palmisani S, Pang D, Wesley S, Park HJ, Raza A, Agnesi F. Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. Neurol Sci. 2021 Aug;42(8):3285-3296. doi: 10.1007/s10072-020-04907-3. Epub 2021 Jan 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2018
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Neck Pain; Upper Limb Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: SJM-CIP-10194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes