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:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT03630133
Eligibility Criteria:
Inclusion Criteria:
* Skeletally mature subjects age 25-70 years, inclusive
* Chronic lower back pain for at least six months
* Failure to respond to at least six months of non-operative conservative management
* Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
* Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1
Exclusion Criteria:
* Radicular pain by history or evidence of pain neurological deficit within the past one year.
* Previous surgery performed on the lumbar spine
* Current or history of symptomatic spinal stenosis
* Current or history of osteoporotic or tumor-related vertebral body compression fracture
* Current or history of vertebral cancer or spinal metastasis
* Current or history of spinal infection
* Metabolic bone disease
* BMI greater or equal to 40
* Any radiographic evidence of other important back pathology
* MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Subjects who are bed bound
* Demonstrates 3 or more Waddell's signs of Inorganic Behavior
* Any evidence of current systemic infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT03630133
Study Brief:
Protocol Section:
NCT03630133