Clinical trial NCT06626334: Blue Light As an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
Official title: Blue Light As an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma: a Randomized Controlled Trial in Adults with Rib Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rib Fractures
Pain, Acute
Keywords: Light Therapy
Blue Light Therapy
Pain Control
Analgesia
Immunomodulation
Bright Light Therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-10-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants who provide informed consent will be randomized 1:1:1 to bright blue light intervention, bright full-spectrum (white) light comparison, and usual light control arms. Permuted block randomization with random block sizes and stratified by age (less than 65 years, greater than or equal to 65 years) will be used for allocation to the three study arms. Assigned lighting interventions will be administered using commercially-available light therapy lamps (Day\*Light Classic Plus) fitted with appropriate filters (LEE Filters) and mounted on stands with rolling casters to facilitate bedside use.
Primary purpose: TREATMENT

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.
* They will be asked to wear a heart monitor to look for changes in their heart rate.
* 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 24 hours of traumatic injury
* Greater than or equal to 1 acute rib fracture
* Pain related to rib fracture(s), scoring greater than or equal to 4/10 on NRS with incentive spirometer use at the time of informed consent
* 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, 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

Primary outcomes:
measure: Chest wall pain intensity, with incentive spirometer use
timeFrame: Up to 72 hours (assessed twice daily)
Secondary outcomes:
measure: Intensive care unit-free days
timeFrame: 30 days
measure: Rev-Erb alpha expression
timeFrame: Up to 72 hours (blood samples collected daily)
measure: IL-6 concentration
timeFrame: Up to 72 hours (blood samples collected daily)
measure: TNF-alpha concentration
timeFrame: Up to 72 hours (blood samples collected daily)
measure: IL-10 concentration
timeFrame: Up to 72 hours (blood samples collected daily)
measure: Opioid requirements
timeFrame: Up to 72 hours (calculated daily)
measure: Chest wall pain intensity, at rest
timeFrame: Up to 72 hours (assessed twice daily)
measure: Hospital-free days
timeFrame: 30 days
measure: Incidence of in-hospital delirium
timeFrame: At 72 hours or date of discharge (assessed daily)
measure: Incidence of pulmonary complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Presbyterian Hospital, University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rebecca E Kotcher, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Yuan D, Collage RD, Huang H, Zhang X, Kautza BC, Lewis AJ, Zuckerbraun BS, Tsung A, Angus DC, Rosengart MR. Blue light reduces organ injury from ischemia and reperfusion. Proc Natl Acad Sci U S A. 2016 May 10;113(19):5239-44. doi: 10.1073/pnas.1515296113. Epub 2016 Apr 25.
citation: Lewis AJ, Zhang X, Griepentrog JE, Yuan D, Collage RD, Waltz PK, Angus DC, Zuckerbraun BS, Rosengart MR. Blue Light Enhances Bacterial Clearance and Reduces Organ Injury During Sepsis. Crit Care Med. 2018 Aug;46(8):e779-e787. doi: 10.1097/CCM.0000000000003190.
citation: Griepentrog JE, Zhang X, Lewis AJ, Gianfrate G, Labiner HE, Zou B, Xiong Z, Lee JS, Rosengart MR. Frontline Science: Rev-Erbalpha links blue light with enhanced bacterial clearance and improved survival in murine Klebsiella pneumoniae pneumonia. J Leukoc Biol. 2020 Jan;107(1):11-25. doi: 10.1002/JLB.4HI0519-155R. Epub 2019 Aug 4.