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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT02089750
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years old
2. Subjects must be symptomatic with current pain between T12 and the SI joints with or without radiating pain at an average score of 4 or higher on the NPRS scale
3. Symptoms must have been present for at least three months
Exclusion Criteria:
1. Use of custom-made orthotics in the past 6 months
2. Ongoing active conservative care (such as physical therapy or chiropractic care) for the low back, leg, or foot received in the past 6 months (excluding the use of oral medications or daily at-home exercises for general well-being).
3. Current or future litigation for any healthcare concern
4. Not fluent or literate in the English language. We will not be able to provide multiple translators within this study
5. Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion
6. Chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis
7. Clinically significant chronic inflammatory spinal arthritis
8. Spinal pathology or fracture
9. Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
10. History of bleeding disorder
11. Known arterial aneurysm
12. Previous lumbar spine surgery
13. Severe skeletal deformity of the foot
14. Peripheral neuropathy due to disorders such as diabetes
15. Low back pain that is not reproducible
16. Current pregnancy
17. Other conditions that may affect the subjects' ability to participate throughout the duration of the study or exclude patients from participation in the study, including contraindications to orthotic use or chiropractic spinal manipulations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02089750
Study Brief:
Protocol Section:
NCT02089750