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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT01726803
Eligibility Criteria:
Inclusion Criteria:
* Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
* Age 18 - 60 years
* Oswestry disability score \> 20%
* Both of the following clinical decision rule criteria: a)Duration of current symptoms \< 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.
Exclusion Criteria:
* Prior surgery to the lumbosacral spine
* Any treatment for low back pain in past 6 months
* Current pregnancy
* Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
* Presence of neurogenic LBP defined as the presence of either of the following:
a) Positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at \<45 degrees); or b)Reflex, sensory, or strength deficits in a pattern consistent with lumbar nerve root compression
* Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection or systemic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01726803
Study Brief:
Protocol Section:
NCT01726803