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

NCT03159169 | Terminated FDA Device

• 1 other identifier: SJM-CIP-10194
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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

Conditions

Neck Pain; Upper Limb Pain

Keywords

Neck Pain; Upper Limb Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate the change in pain intensity between baseline, trial and long-term follow up evaluations using Visual Analog Scale (VAS) assessments.

  Golden standard self-evaluation of pain intensity

  3, 6 and 12 months

Study Arms (1)

study patients

EXPERIMENTAL

Single arm study. Patients will receive Spinal Cord Stimulation (SCS) according to standard clinical procedures.

Device: Spinal Cord Stimulation (SCS)

Interventions

Spinal Cord Stimulation (SCS) DEVICE

Implantation of SCS electrodes and stimulator according to clinical standards

study patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Southmead hospital

Bristol, United Kingdom

Location

Guy's St. Thomas Hospital

London, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33387056 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Adnan Al-Kaisy, MD

  Guy's St. Thomas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 18, 2017
• Study Start: May 15, 2018
• Primary Completion: April 30, 2022
• Study Completion: August 31, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)