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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT01966250
Eligibility Criteria:
Inclusion Criteria:
* Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
* Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
* Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
* Patients who are 19 - 70 years of age.
* Patients who agreed to voluntarily participate in this study and signed informed consent.
Exclusion Criteria:
* Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
* Patients with progressive neurological deficit or severe neurological symptoms.
* Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
* Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
* Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
* Patients who are currently pregnant or planning the pregnancy.
* Patients with psychiatric diseases.
* Patients who are participating in other clinical trial.
* Patients who are unable to sign informed consent.
* Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01966250
Study Brief:
Protocol Section:
NCT01966250