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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT04562493
Eligibility Criteria:
Inclusion Criteria:
Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
1. Clinical evidence of disc pulge in the form of disc related radicular pain of \>3 months duration, not responding to conservative treatment and interfering with daily activities
2. Radiological demonstration of posterolateral lumbar disc pulge by MRI lumbosacral
3. Age range is between 30-80 years
Exclusion Criteria:
The following patients will be excluded from the study:
1. Patients with spinal deformities
2. Patients with a previous history of spinal trauma
3. Patients with previous spinal surgery
4. Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the spinal cord or vertebral column
5. Patients with severe lumbar disc herniation causing lower limb weakness or sphincteric troubles
6. Patient with pain rather than radicular neuropathic pain as Facet osteoarthritis, Sacroiliitis, Hip osteoarthritis, Discogenic, Pyriformis syndrome.
7. Patients with contraindications to interventions (coagulopathy, sepsis, or allergy to the used drugs)
8. Patients with contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
9. Pregnant
10. History of G6PD deficiency in patients who are candidates to receive ozone therapy.
11. Suspected spondylodiscitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT04562493
Study Brief:
Protocol Section:
NCT04562493