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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT02391350
Eligibility Criteria:
Inclusion Criteria:
1. Symptoms of pain and/or numbness between the 12th rib and buttocks, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
2. Symptoms of pain and/or numbness primarily into one leg that have extended below the knee in the last 72 hours, and correspond to a lower lumbar nerve root distribution (L4, L5, S1)
3. Current symptoms present for 90 days or fewer
4. Oswestry disability score \> 20%
5. One or more of the following symptoms:
* Positive ipsilateral or contralateral straight leg raise test (reproduction of symptoms at \<70 degrees)
* Reflex, sensory, or strength deficits in a pattern consistent with lower lumbar nerve root
Exclusion Criteria:
1. Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past year
2. Current pregnancy
3. Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.) or any treatment for LBP in prior 6 months.
4. Judgment of primary care provider of "red flags" of a potentially serious condition including cauda equina, major or rapidly progressing neurologic deficit, fracture, cancer, infection or systemic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02391350
Study Brief:
Protocol Section:
NCT02391350