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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT02598232
Eligibility Criteria:
Inclusion Criteria:
* Adult patients 19-79 years old
* Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks
* Patients who have language skills enough to answer questionnaires
* Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study
Exclusion Criteria:
* Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc
* Patients who use an electronic medical device for their cardiovascular system
* Patients who have spondylolisthesis in the relevant lesion
* Patients with neurological defects
* Patients who had undergone surgery on the relevant lumbar vertebra
* Patients with cauda equina syndrome
* Patients with congenital spinal deformity
* Patients with spinal fracture
* Patients with spinal infection, tumor, or other form of inflammatory spondylopathy
* Patients with coagulation disorder
* Patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years)
* Patients who had participated in another clinical study within 30 days from their screening visit
* Female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method\* for up to 24 weeks after the use of the investigational medical device during this study
* Medically acceptable contraceptive method: Condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc.
* Patients who are pregnant or breastfeeding
* Other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT02598232
Study Brief:
Protocol Section:
NCT02598232