| Eligibility |
Inclusion Criteria:
- A subject must MEET ALL of the following inclusion criteria:
1. Be diagnosed with chronic, intractable pain of the upper limb related to the
cervical spine and/or neuropathic arm pain.
2. Be a candidate for SCS system (trial and implant) per labeled indication (upper
limb pain due to one of the conditions listed in indications statement)
3. Considering daily activity and rest, has average upper limb pain intensity of = 5
out of 10 cm on the Visual Analog Scale (VAS) at enrollment
4. Be willing and capable of giving written informed consent to participate in this
clinical study based on voluntary agreement after a thorough explanation of the
subject's participation has been provided.
5. Be willing and capable of subjective evaluation, read and understand written
questionnaires, and read, understand and sign the written inform consent.
6. Be 18 years of age or older at the time of enrollment
7. Be on a stable pain medication regime, as determined by the study investigator,
for at least 30 days prior to enrolling in this study
8. Be willing and able to comply with study -related requirements, procedures, and
visits, including not increasing pain meds through the three month visit
9. Has adequate cognitive ability to use a patient programmer and recharger as
determined by the Investigator
Exclusion Criteria:
- A subject must NOT MEET ANY of the following exclusion criteria:
1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated
for commercially available IntellisTM SCS systems as determined by the
Investigator
2. 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
3. Currently enrolled or planning to enroll in an interventional clinical study that
could potentially confound the study results (co-enrollment in an interventional
study is only allowed when documented pre-approval is obtained from the study
manager or designee)
4. Has an existing active implanted device such as a pacemaker, another SCS unit,
peripheral nerve stimulator, and/or drug delivery pump.
5. Has pain in other area(s) and/or medical condition requiring the regular use of
significant pain medications that could interfere with accurate pain reporting,
study procedures, and/or confound evaluation of study endpoints, as determined by
the Investigator
6. Has significant cervical stenosis, as determined by the Investigator
7. Has facet spondylosis, as determined by the Investigator
8. Has mechanical spine instability, as determined by the Investigator
9. Has undergone, within 30 days prior to enrollment, an interventional procedure
and/or surgery to treat upper limb pain, which is providing significant pain
relief
10. Has unresolved major issues of secondary gain (e.g., social, financial, legal,
such as worker compensation matters)
11. Be pregnant as determined by urine testing unless female subject is surgically
sterile or post-menopausal. If female, sexually active, and childbearing age,
subject must be willing to use a reliable form of birth control.
12. Have evidence of an active disruptive psychological or psychiatric disorder as
determined by a psychologist
13. Have a current diagnosis of a progressive neurological disease as determined by
the Investigator
14. Have a current diagnosis of a coagulation disorder, bleeding diathesis,
progressive peripheral vascular disease or uncontrolled diabetes mellitus
15. Have a condition that the Investigator determines would significantly increase
perioperative risk
16. Any previous history of surgery on the posterior elements (laminectomy, posterior
fusion) of the cervical spine
17. Have metastatic malignant disease or active local malignant disease
18. Have a life expectancy of less than 1 year
19. Have an active systemic or local infection
20. 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)
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