NCT06626334 · Rebecca E Kotcher, MD
Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
(BLAASTT)
What this study is about
The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations