NCT06626334 Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
| NCT ID | NCT06626334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rebecca E Kotcher, MD |
| Condition | Rib Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2024-10-23 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures. The main question it aims to answer is: \- Does bright blue light therapy in addition to standard pain treatments improve pain with breathing in adults with painful rib fractures? Researchers will compare participants who receive bright blue light therapy to participants who receive white light therapy and participants who receive only usual lighting conditions to look for differences in their pain control. In addition to their assigned light treatment, all participants will receive standard pain control treatments. Participants will be assigned randomly to one of three groups: one-third will be assigned to bright blue light therapy, one-third will be assigned to bright white light therapy, and one-third will be assigned to usual light only. They will receive their assigned light treatment for 4 hours during the morning/early afternoon for up to 3 days while they are in the hospital. On each day they receive the light treatment and on the day after their final light treatment: * They will be asked twice to rate their pain at rest and with taking a deep breath. * They will be tested to confirm that they are not experiencing delirium, or confusion related to being in the hospital. * Blood samples will be collected to look for changes in inflammation and the circadian clock, the body's natural 24-hour cycle.
Eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 18 years * Admitted to a single large academic level I trauma center (Presbyterian/Montefiore hospital) within the first 48 hours of traumatic injury * Greater than or equal to 1 acute rib fracture * Pain related to rib fracture(s), by one or more of the following criteria: 1. Pain \>/= 4/10 at rest, 2. Pain \>/= 4/10 with incentive spirometer (IS) use, and/or 3. Inspiratory volume \< 1000 cc * Anticipated length of stay greater than or equal to 48 hours * Alert, with capacity to provide informed consent Exclusion Criteria: * Mechanical ventilation\* or non-invasive positive pressure ventilation administered for respiratory insufficiency prior to the time of informed consent * Delirium (positive CAM screening) at the time of informed consent * Ocular trauma, which may interfere with the mechanism of action * Traumatic brain injury (TBI) or history of TBI or stroke, which may interfere with the mechanism of action * Splenectomy upon admission or history of splenectomy, which may interfere with the mechanism of action * History of significant ocular dysfunction\*\* (i.e., macular degeneration, glaucoma, cataracts), which may interfere with the mechanism of action * History of cataract surgery, due to the possibility of blue light filtering intraocular lens placement * History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania) * History of dementia, which would compromise the reliability of pain intensity and delirium measures * Or other condition in which a patient cannot open eyes to receive light intervention or report a pain score \*\*Myopia, hyperopia, and/or astigmatism corrected for with contact lenses or spectacle corrective eyeglasses will NOT be a criterion for exclusion
Contact & Investigator
Rebecca E Kotcher, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06626334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rib Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06626334 currently recruiting?
Yes, NCT06626334 is actively recruiting participants. Contact the research team at kotcherre@upmc.edu for enrollment information.
Where is the NCT06626334 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06626334 clinical trial?
NCT06626334 is sponsored by Rebecca E Kotcher, MD. The principal investigator is Rebecca E Kotcher, MD at University of Pittsburgh. The trial plans to enroll 75 participants.