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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT06755593
Eligibility Criteria:
Inclusion Criteria:
* Adults aged ≥ 18 years.
* Diagnosis of chronic sciatica pain lasting ≥ 3 months.
* Sleep disturbance defined by a Pittsburgh Sleep Quality Index (PSQI) score \> 5.
* Pain intensity score ≥ 50 mm on a 100-mm Visual Analog Scale (VAS).
* Able to walk independently (with or without walking aids).
* Provided written informed consent to participate in the study.
Exclusion Criteria:
* Malignant diseases, autoimmune diseases, or systemic inflammatory disorders.
* History of prior spinal surgery.
* Acute low back pain of \< 4 weeks' duration.
* Primary sleep disorders (e.g., narcolepsy, sleep apnea, circadian rhythm disorders).
* Diagnosed psychiatric conditions such as depression, anxiety, or delirium.
* Current use of psychotropic, antidepressant, hypnotic, corticosteroid, or antihistamine medications.
* Contraindications to low-level intravascular laser irradiation (e.g., hemophilia, acute myocardial infarction, acute stroke within 72 hours, active infection, pregnancy).
* Signs or suspicion of severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome).
* Concurrent involvement of lumbosacral nerve roots, plexus, or peripheral neuropathy confirmed by electrodiagnostic testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06755593
Study Brief:
Protocol Section:
NCT06755593