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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06671132
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-85.
2. Pain duration \> 6 months.
3. Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener \>3.
4. Average pain score of \> 5/10, with low back pain being the primary pain site. (5) CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III.
(6) Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture.
(7) For those taking opioids (the opioid subgroup), participants must be prescribed opioids currently for at least 3 consecutive months prior to enrollment. Such patients must be on opioids for a minimum of three months, taking them daily or intermittently during the week. (8) Subject must agree that opioids cannot be increased during the study. (9) No substance use disorder (SUD), except tobacco in the past year based on substance screening survey and frequent urine toxicology screens. (10) No acute suicidality, mania, or psychosis. This will be assessed at study entry, which will also include a review of history in the EHR, Diagnostic Interview for Genetic Studies (DIGS) and Columbia Suicide Severity Rating scale (C-SSRS) and (11) Finally, participants must sign IRB-approved consent.
Exclusion Criteria:
1. Back surgery within the past six months.
2. Active worker's compensation or litigation claims.
3. New pain and/or psychiatric treatments within 2 weeks of enrollment.
4. Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications.
5. Intent to add new psychiatric treatments during the first 3 months of the study.
6. Any clinically unstable systemic illness that is judged to interfere with the trial.
7. History of cardiac, nervous system, or respiratory disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for respiratory depression.
8. Non-ambulatory status.
9. Pregnancy or the intent to become pregnant during the study. Women of childbearing age will have urine pregnancy testing at enrollment and monthly. (10) Anosmia or significant nasal disease
(11) Contraindications to MRI (12) Stroke or TBI (traumatic brain injury).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06671132
Study Brief:
Protocol Section:
NCT06671132