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 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT04644757
Eligibility Criteria:
Inclusion Criteria:
* self-report of Lower back pain (LBP)
* LBP in the past 3 months with an average rating of at least 30 on a 0 - 100 NRS for pain
* intact cognition
* no plans to change their pain medication regimens during the study time
* can read and understand English
* can travel to the study center
* agree to sign an informed consent
Exclusion Criteria:
* deaf or have severe hearing loss
* pregnant or lactating
* have an implantable pain-reducing device
* history of hospitalization within the preceding year for psychiatric illness
* diagnosis of Raynaud's disease
* have a functional limitation that requires the use of an ambulatory aid such as a cane, walker, or wheelchair
* history of brain surgery, brain tumor, or stroke
* severe depression (PROMIS Depression T-score ≥ 70) (Kroenke et al., 2020)
* severe anxiety (PROMIS Anxiety ≥ 70) (American Psychiatric Association, 2013)
* Mini-Mental State Examination score less than 24 (Creavin, Wisniewski, Noel-Storr, et al., 2016)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04644757
Study Brief:
Protocol Section:
NCT04644757