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 @ 8:01 PM
Ignite Modification Date:
2025-12-24 @ 8:01 PM
NCT ID:
NCT03958604
Eligibility Criteria:
Inclusion Criteria:
* able and willing to comply with the follow-up schedule and protocol
* Subject is able to provide written informed consent
* Chronic low back pain of at least 6 months
* History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
* Subject has a negative test block of facet joints in the sacroiliac joint.
* Neurologic exam without marked motor deficit.
* Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to International Association for the Study of Pain (IASP/ISIS) guidelines
* Low Back Pain intensity should be 6 or higher measured on a Numeric Pain Rating Scale(NPRS) at baseline
* Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center
* Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
Exclusion Criteria:
* Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
* Escalating or changing pain condition within the past month as evidenced by investigator examination
* Body Mass Index ≥35
* Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
* Subject currently has an active implantable device including Internal Cardioverter Defibrillator(ICD), pacemaker, spinal cord stimulator, or intrathecal drug pump
* Subject is unable to operate the device
* Severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs of ComputoTomography (CT)/Magnetic Resonance Imaging(MRI).
* Extruded or sequestered herniated nucleus pulposus at the affected level(s).
* Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
* Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
* Moderate to severe endplate degenerative changes at the affected levels Grade 1-2 spondylolisthesis
* Previous Neurostimulation(SCS) therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03958604
Study Brief:
Protocol Section:
NCT03958604