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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00370695
Eligibility Criteria:
Inclusion Criteria:
* Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment.
* Be 18 years of age or older.
* Be an appropriate candidate for the surgical procedures required for SCS implant.
* Be willing and able to comply with all study related procedures and visits.
* Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion Criteria:
* Have had any back or spine surgery.
* Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery.
* Have any other chronic pain conditions likely to confound evaluation of study endpoints.
* Are a current substance abuser (including alcohol and illicit drugs).
* Have a significant psychiatric disorder.
* Have a condition currently requiring or likely to require the use of MRI or diathermy.
* Have an active implantable device.
* Are pregnant or lactating or planning to become pregnant in the next year.
* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00370695
Study Brief:
Protocol Section:
NCT00370695