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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Neck Pain, Upper Limb Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation (SCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study patients<br>Single arm study. Patients will receive Spinal Cord Stimulation (SCS) according to standard clinical procedures. | Device: Spinal Cord Stimulation (SCS)<br>* Implantation of SCS electrodes and stimulator according to clinical standards<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck Pain, Upper Limb Pain