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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05669027
Eligibility Criteria:
Inclusion Criteria:
1. Responding greater than 3 months to "How long has low back pain been an ongoing problem for you?"
2. Responding 'at least half the days' to "How often has low back pain been an ongoing problem for you over the past 6 months?"
Investigators will follow recommendations to items and responses provided by the NIH Task Force on Research Standards for Chronic Low Back Pain, which specifically: "recommended 2 questions to achieve the definition of chronic low back pain: (1) How long has back pain been an ongoing problem for you? (2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of 'at least half the days in the past 6 months' to question 2 would define chronic lower back pain."
Exclusion Criteria:
1. History of seizures.
2. Planning pain-related surgery in the next 9 months.
3. Individuals with implanted medical devices that could experience interference during EEG and/or ECG, such as a spinal cord stimulator or pacemaker.
4. Lower back pain is associated with compensation or litigation issues.
5. Rating of past week pain intensity\<4 on 0-10 point scale.
6. Rating of past week pain interference\<4 on 0-10 point scale.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05669027
Study Brief:
Protocol Section:
NCT05669027