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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT04559295
Eligibility Criteria:
Inclusion Criteria:
* A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain
* Patients with mild to severe spinal stenosis
* Patients with radiculopathy
* Patients with disc extrusions
* Patients with failed spinal fusion
* Patients with mild to severe facet arthropathy
* Patients with suspected sacroiliac joint disease
* Age 18 to 60 years
* Mild to severe loss of intervertebral disc height
* Pain is not responsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)
* Pain persists for an extended period of time (i.e., at least 3 months)
* High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI
* No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
* English speaking
Exclusion Criteria:
* Spinal Deformity (Scoliosis \>20 degrees, Spondylolisthesis)
* Sequestered fragments, severe thecal sac compression
* Severe neurologic deficit
* Non-English speaking
* Bone marrow disorders
* Immunosuppressed Patients
* Patients with coagulopathy
* Localized infection in the area of skin penetration
* Spinal infection
* Serious medical co-morbidities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04559295
Study Brief:
Protocol Section:
NCT04559295