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:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT02020460
Eligibility Criteria:
Inclusion Criteria:
Subjects enrolled in this study must meet the following inclusion criteria:
1. Primary pain type-neuropathic with concordant neurologic findings
2. Subject age is 18 years or older;
3. Subjects who meet one of the following four criteria:
1. diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome or failed back surgery syndrome.
2. previously had successful SCS, but gradually became refractory
3. did not have adequate coverage during a prior SCS trial,
4. been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration
4. Disease duration of at least 6 months with no lasting success with standard therapy and medications.
5. Mean pain intensity of at least 5 cm (or greater), measured on a visual analog scale from 0 (no pain) to 10 cm (severe pain) on a 10 cm line;
6. Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate;
7. Subject is willing to cooperate with the study requirements including compliance with the treatment regimen, the follow-up visit schedule and completion of the study diary;
8. Female candidates of childbearing potential must have a negative serum pregnancy test.
9. MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) rules out a pathology that might compromise SCS electrode placement or pathology, in addition to neural compression that might contribute to the subject's pain
10. Provide informed consent to participate in the study; -
Exclusion Criteria:
A subject will be excluded from participation in this study if they meet any one of the following criteria:
1. Pain attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis;
2. Subjects currently participating in another clinical trial;
3. Subject has an existing intrathecal drug pump
4. Active local or systemic infection
5. Unresolved issues of secondary gain (e.g., litigation)
6. Expected inability to adequately report treatment outcome
7. A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthritis of the hip associated with groin pain as primary complaint)
8. Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis.
9. Subjects who have a condition that requires diathermy or repeat MRI's;
10. New medication for pain control has been initiated within 8 weeks prior to the initial baseline;
11. Female candidates of child bearing potential who are pregnant (confirmed by positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child;
12. Subject has a blood clotting disturbance or requires chronic anticoagulant drug therapy
13. The Investigator deems that the subject is not suitable for the study even if they meet all other inclusion/exclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02020460
Study Brief:
Protocol Section:
NCT02020460