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 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT00706459
Eligibility Criteria:
Inclusion Criteria for Patient with classic discogenic back pain:
* age range 25-60 years old
* Back and/or leg (back\>leg) pain
* Degenerative disc disease in one or more adjacent vertebral levels between L3-S1
* Radiologic confirmation of degenerative disc disease:
* Segmental instability (3 mm translation or 5 degree angulation)
* Decreased disc height \>2 mm
* Scarring, thickening of annulus fibrosis
* Vacuum phenomenon
* No significant foraminal stenosis and nerve root compression
* Failed observative treatment for at least 6 months
* Oswestry LB disability questionnaire score of at least 20/50 (40%) (interpreted as moderate to severe disability)
* Psychosocially and mentally normal
* Patients who are scheduled for back surgery
Inclusion criteria for patients with degenerative disc disease without the classic discogenic back pain:
* Age range 25-60 years old
* Patients with diagnosis of idiopathic scoliosis, spondylolysis, or spondylolisthesis
Inclusion criteria for normal controls:
* No symptoms
* Age range 25-60 years old
Inclusion Criteria for post-surgical discectomy patients:
* Patients who had successful disc surgery for lumbar herniated disc and no further back pain
* Patients who had unsuccessful disc surgery for lumbar herniated disc and still with residual back pain
Exclusion Criteria:
* prior back surgery (except as mentioned above)
* spine fractures
* Radiographic confirmation of facet joint disease or degeneration
* Radiographic confirmation of sacroiliac joint pathology
* Lytic spondylolisthesis of spinal stenosis
* Degenerative spondylolisthesis of \> grade 1
* Metabolic bone disease
* Spine infection , osteomyelitis
* Rheumatoid arthritis or any other systemic or autoimmune disease
* Active malignancy
* MRI Contraindications (fragment in eye, aneurysms clips, ear implants, spinal nerve stimulators, pacemaker, claustrophobia, or pregnant women, etc.,)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT00706459
Study Brief:
Protocol Section:
NCT00706459