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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT07035093
Eligibility Criteria:
Inclusion Criteria:
* Have a history of axial-predominant low back pain
* Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs
* Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Exclusion Criteria:
* Have a non-axial origin low back pain
* Have had botulinum or steroid injections to the spine within 1 year of screening
* Have had trigger point injection to the spine within 6 months of screening
* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days prior to screening
* Have been taking drugs to promote body weight reduction, including over-the-counter medications, within 90 days prior to screening
* Have a prior or planned surgical treatment for obesity
* Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07035093
Study Brief:
Protocol Section:
NCT07035093