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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT03107468
Eligibility Criteria:
Inclusion Criteria:
* Individuals with all the following requirements will be included as appropriate subjects in the clinical trial:
1. Those aged from 19 to 78 years
2. Those with a diagnosis of degenerative lumbar spinal spondylolisthesis and have low back pain, lower limb radiating pain, or leg discomfort when standing or walking with severity of at least 50 in a 0 to 100 VAS for each symptom
3. Those suffering from neurologic claudication or radicular pain at least for one year
4. Those with neurogenic claudication within five minutes when walking on a treadmill at the speed of 1.5 miles per hour
5. Those not receiving epidural injection treatments within the past one month
6. Those who have not undergone lumbar surgery
7. Those who confirmed spondylolisthesis on L-spine AP, lateral \& both oblique views
8. Those who weigh 250 lbs (113.398 kg) or less
9. Those who are 2.1 m (6.890 ft) in height or shorter
10. Those agreeing to participate in this clinical trial after receiving a thorough explanation of the purposes and characteristics of the trial and who have also signed the written informed consent form.
Exclusion Criteria:
* Subjects will be excluded for the following conditions:
1. Those with a history of diseases in the past or in the present that cause ambulatory functional disability
2. Those with knee joint and hip joint disorders that severely limit walking (i.e. moderate or severe osteoarthritis in the knee or hip joints)
3. Those who has been diagnosed as peripheral blood vessel diseases or vascular diseases in the past, shows an ankle-brachial index (ABI) below 0.9 or is diagnosed as peripheral artery disease by Doppler ultrasonography of lower limbs, if necessary
4. Those with severe diseases (cardiac disorders or renal insufficiency) such that the ambulatory evaluation is not attainable
5. Those with other specific spinal diseases (ankylosing spondylitis, spinal osteomyelitis, metabolic diseases, severe osteoporosis, etc.)
6. Those with severe neurological defects including foot drop or cauda equina syndrome
7. Those with spinal instability confirmed by L-spine x-ray flexion and extension views. Spinal instability will be defined as observing one or more of the following: 4.5 mm sagittal plane translation, 20 degrees of sagittal plane rotation at L4-5, or 25 degrees of sagittal plane rotation at L5-S1.
8. Those with malignancy
9. Those with psychiatric conditions such as major depressive disorder and anxiety disorder in the past or present (e.g., panic disorder, episodes of mania, delusion, and schizophrenia)
10. Those using narcotic analgesics, including the external dosage form or patch
11. Those on medications for respiratory diseases including gastritis, stomach ulcer, and irritable bowel syndrome
12. Pregnant women, lactating women, or those planning to become pregnant
13. Those who appear likely to encounter difficulties in adhering to this protocol such as those regarding treatment, hospitalization, or preparation for the survey
14. Those subjects who the clinical investigators judge to be inappropriate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
78 Years
Study:
NCT03107468
Study Brief:
Protocol Section:
NCT03107468