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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT05086159
Eligibility Criteria:
Inclusion Criteria:
* Pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region
* Current episode of back pain duration of 3 months or longer
* Active duty military or Veteran
* Read and speak English well enough to provide informed consent and follow study instructions
Exclusion Criteria:
* History of prior surgery to the lumbosacral spine within the previous 12 months
* Presence of neurogenic LBP defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
* Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
* Discharged from physical therapy within the past 3 months for lower back pain
* Current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality disorder).
* Substance abuse or psychosis within 6 months of research.
* Unable to discontinue other active therapies until completion of clinical trial follow-up (8 weeks).
* Suicidal ideation
* Current pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05086159
Study Brief:
Protocol Section:
NCT05086159