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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT06024460
Eligibility Criteria:
Inclusion Criteria:
* aged 19 to 69 years.
* lower back pain that has persisted for at least 1 month.
* a Numeric Rating Scale (NRS) score of 5 or higher for either lower back pain or radiating leg pain over the past three consecutive days.
* confirmed lumbar disc herniation on MRI that can explain the lower back pain.
* who have provided written informed consent and agreed to participate in the clinical study.
Exclusion Criteria:
* diagnosed with specific severe diseases that could be the cause of lower back pain or leg pain (e.g., spinal metastasis, acute fractures, and spinal dislocation).
* showing progressive neurological deficits or severe neurological symptoms.
* with pain originating from soft tissue disorders other than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
* with other chronic conditions (e.g., stroke and myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy) that may interfere with the treatment effect or result interpretation.
* taking steroids, immunosuppressive drugs, psychiatric medications, or other medications that may impact the study results.
* acupuncture or nerve block treatment is inappropriate or unsafe, such as those with a history of bleeding disorders, receiving anticoagulant therapy, or diagnosed with uncontrolled diabetes.
* taken non-steroidal anti-inflammatory drugs (NSAIDs) or other pain-affecting drugs or received acupuncture treatment within the past 5 days.
* Pregnant women, those planning pregnancy, or breastfeeding women.
* within 3 months after lumbar surgery.
* who have not completed participation in another clinical study within the past month or have plans to participate in another clinical study within 6 months from the selection date or during the study participation and follow-up period.
Inability to provide written informed consent.
\- Other cases where the researchers determine that participation in the clinical study would be difficult.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
69 Years
Study:
NCT06024460
Study Brief:
Protocol Section:
NCT06024460