Clinical Trial of the Senza™ SCS System in the Treatment of Chronic Upper Limb and Neck Pain (SENZA-ULN)

This is an interventional treatment trial for Neck Pain Read More

Inclusion Criteria:

1. Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain
2. Considering daily activity and rest, have average upper limb and/or neck pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device
5. Be 18 years of age or older at the time of enrollment
6. Be willing and capable of giving informed consent
7. Be willing and able to comply with study-related requirements, procedures, and visits
8. Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
9. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

Exclusion Criteria:

1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
2. Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
3. Have a current diagnosis of a progressive neurological disease as determined by the Investigator
4. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
5. Have a condition that the Investigator determines would significantly increase perioperative risk
6. Significant cervical stenosis
7. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion)
8. Be benefitting within from an interventional procedure and/or surgery to treat upper limb pain (Subjects should be enrolled at least 30 days from last benefit)
9. Have an existing drug pump and/or another active implantable device such as a pacemaker
10. Have a condition currently requiring or likely to require the use of MRI or diathermy
11. Have metastatic malignant disease or active local malignant disease
12. Have a life expectancy of less than 1 year
13. Have an active systemic or local infection
14. Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
15. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
16. Be concomitantly participating in another clinical study
17. Be involved in an injury claim under current litigation -