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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06318156
Eligibility Criteria:
Inclusion Criteria:
* Age range of 18 to 65 years, regardless of gender.
* Radiological confirmation of central type L4\~L5 intervertebral disc herniation.
* Meeting the diagnostic criteria for lumbar disc herniation, primarily manifesting as lower back pain, radicular pain, and numbness or weakness in the lower limbs, with imaging findings consistent with neurological localization.
* Patients in the non-acute phase of mild to moderate pain and functional impairment (onset more than 2 weeks ago), with a visual analog scale (VAS) score greater than 4 points and a Japanese Orthopaedic Association (JOA) score less than 15 points.
* No consumption of analgesics, neurotrophic drugs, or sedatives, and no systemic treatment in the past week.
* Willing participants in the study who have signed an informed consent form.
Exclusion Criteria:
* Concomitant internist and gynecological diseases that can cause lower back pain, such as nephritis, urinary tract stones, gynecological inflammations, and uterine pathologies.
* Individuals with severe primary diseases of the cardiovascular, cerebrovascular, liver, kidney, etc.
* Patients with neurosis or psychiatric disorders, or those with a history of cranial trauma or coma.
* Patients with primary or ankylosing sciatica.
* Individuals with concomitant lumbar spondylolisthesis.
* Patients with lumbar spine tumors or tuberculosis.
* Individuals with consciousness disorders, severe impairments in vision, hearing, or speech, or any other condition that prevents the completion of a health assessment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06318156
Study Brief:
Protocol Section:
NCT06318156