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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT01611792
Eligibility Criteria:
Inclusion Criteria:
* a history of chronic LBP with or without recurrences for a minimum of 12 months
* between 21 - 55 years of age
* able to stand and walk without assistance
* have an Oswestry Disability Score of 19% or higher
Exclusion Criteria:
* any major structural spinal deformity including scoliosis, kyphosis, or stenosis
* spinal fracture or dislocation
* osteoporosis
* ankylosing spondylitis
* rheumatoid arthritis
* disc herniation with corroborating clinical signs and symptoms
* serious spinal complications such as tumor or infection
* previous spinal surgery
* frank neurological loss, i.e., weakness and sensory loss
* pain or paresthesia below the knee
* etiology of LBP other than the lumbar spine, e.g., hip joint
* history of neurological disease which required hospitalization
* active treatment for cancer
* history of unresolved cancer
* pregnancy or less than 6 months post-partum or less than 6 months post weaning
* magnified symptom-behavior
* worker's compensation or disability case
* in litigation for the LBP problem
* have a BMI ≥ 30
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT01611792
Study Brief:
Protocol Section:
NCT01611792