Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT03380104
Eligibility Criteria:
Inclusion Criteria:
* Patients with neuropathic pain and concordant neurological findings previously consented for an epidural spinal cord stimulator trial
* Patients greater than 18 years of agree
* Must have one of the following:
1. Diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome, or failed back surgery syndrome and planning to undergo a spinal cord stimulation trial
2. Been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotic administration
* Disease duration of at least 6 months with no lasting success with standard therapies or medications with exception of spinal cord stimulation
* Mean pain intensity of a least 5 (or greater) measured on a visual analogue scale from 0 (no pain) to 10 (severe pain)
* MRI or CT Myelogram of the lumbar and thoracic spine (within 12 months prior to screening)
* No compressive spinal pathology or intradural implants (eg., syrinx shunt tubes)
* Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate
* Female patients of childbearing potential must have a negative serum pregnancy test
* Patients agree to comply with the study protocol and have reviewed and given written informed consent
Exclusion Criteria:
* Patients who are unable or unwilling to provide feedback regarding the response
* Subject has an existing intrathecal drug pump
* Pain is attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis
* Subject is currently enrolled in another trial
* History of coagulation disorders or patients on chronic anticoagulant or antiplatelet therapy that is not able to be safely held for 14 days
* History of thoracic trauma or spinal surgery extending into the thoracic spine
* History of arachnoiditis or intradural spinal surgery that would limit catheter insertion to the target site
* Current clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of the study endpoints (i.e. chronic migraine, significant arthritis of the hip associated with primary groin pain complaint)
* Radiographic evidence of frank spinal instability (gross mobile spondylolisthesis or abnormal subluxation requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis
* Subject has a condition that requires diathermy or repeated MRIs
* New medication for pain initiated within 8 weeks prior to initial baseline research evaluation
* Life expectancy less than 3 months
* Systemic infection or local infection of the spine or skin in the anticipated region of catheter insertion.
* Immune deficiency or history of post surgical infection
* Female candidates of childbearing potential who are pregnant (confirmed with a positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child
* Untreated or active psychiatric condition
* Complex regional pain syndrome or other condition that could limit testing or aggravate an ongoing medical condition
* Unresolved issues of secondary gain (i.e. litigation)
* The investigator deems that the subject is not suitable for the study even if they meet all other inclusive/exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03380104
Study Brief:
Protocol Section:
NCT03380104