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

Neck Pain Clinical Trial

— NU-BURST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03159169
• Other study ID #: SJM-CIP-10194
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: August 2022

Study information

• Verified date: April 2021
• Source: Abbott Medical Devices
• Contact: Lalit Venkatesan, Ph.D.
• Phone: +19723098522
• Email: LVenkatesan[@]sjm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Upper Limb Pain

Intervention

Device:
• Spinal Cord Stimulation (SCS)
Implantation of SCS electrodes and stimulator according to clinical standards

Locations

Country	Name	City	State
United Kingdom	Southmead hospital	Bristol
United Kingdom	Guy's St. Thomas Hospital	London
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) for pain	Golden standard self-evaluation of pain intensity	baseline
Primary	Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	end of SCS trial (up to two weeks after electrodes implantation)
Primary	Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	3 months post permanent implant
Primary	Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	6 months post permanent implant
Primary	Visual Analog Scale for pain	Golden standard self-evaluation of pain intensity	12 months post permanent implant
Secondary	EQ-5D - 5L (European Quality of Life) (5D-dimensions); (5L levels)	Self reported questionnaire on quality of life	baseline
Secondary	EQ-5D - 5L	Self reported questionnaire on quality of life	End of SCS trial (up to two weeks after electrodes implantation)
Secondary	EQ-5D - 5L	Self reported questionnaire on quality of life	3 months post permanent implant
Secondary	EQ-5D - 5L	Self reported questionnaire on quality of life	6 months post permanent implant
Secondary	EQ-5D - 5L	Self reported questionnaire on quality of life	12 months post permanent implant
Secondary	ONDI	Disability questionnaire	baseline
Secondary	ONDI (Oswestry neck disability index)	Disability questionnaire	end of SCS trial (up to two weeks after electrodes implantation)
Secondary	ONDI	Disability questionnaire	3 months post permanent implant
Secondary	ONDI	Disability questionnaire	6 months post permanent implant
Secondary	ONDI	Disability questionnaire	12 months post permanent implant
Secondary	Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	end of SCS trial (up to two weeks after electrodes implantation)
Secondary	Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	3 months post permanent implant
Secondary	Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	6 months post permanent implant
Secondary	Patient Global Impression of Change	questionnaire on patient satisfaction with therapeutic outcome	12 months post permanent implant
Secondary	Headache Impact Test	Questionnaire on headache burden	baseline
Secondary	Headache Impact Test	Questionnaire on headache burden	end of SCS trial (up to two weeks after electrodes implantation)
Secondary	Headache Impact Test	Questionnaire on headache burden	3 months post permanent implant
Secondary	Headache Impact Test	Questionnaire on headache burden	6 months post permanent implant
Secondary	Headache Impact Test	Questionnaire on headache burden	12 months post permanent implant
Secondary	Hospital Anxiety and Depression	Questionnaire on anxiety and depression	baseline
Secondary	Hospital Anxiety and Depression	Questionnaire on anxiety and depression	end of SCS trial (up to two weeks after electrodes implantation)
Secondary	Hospital Anxiety and Depression	Questionnaire on anxiety and depression	3 months post permanent implant
Secondary	Hospital Anxiety and Depression	Questionnaire on anxiety and depression	6 months post permanent implant
Secondary	Hospital Anxiety and Depression	Questionnaire on anxiety and depression	12 months post permanent implant