Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
NCT ID: NCT06626334
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2024-10-23
2026-08-31
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bright Blue Light
The light therapy lamp will be covered with a filter selecting for short wavelength blue light (peak 442 nm, intensity \~1400 lux).
Bright Blue Light
Bright blue light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#132, Medium Blue) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Usual Ambient Light
Across all arms, the usual ambient light in the inpatient room will not be modified.
For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions.
For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 12-14 inches from eye level with the on/off switch in the off position. The lamp will be positioned in this manner for 4 hours daily during the morning/early afternoon hours, for up to 3 days.
Bright Full-Spectrum (White) Light
The light therapy lamp will be covered with a filter modifying only the light's intensity (\~1400 lux).
Bright Full-Spectrum (White) Light
Bright full-spectrum (white) light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#211 0.9 ND) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Usual Ambient Light
Across all arms, the usual ambient light in the inpatient room will not be modified.
For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions.
For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 12-14 inches from eye level with the on/off switch in the off position. The lamp will be positioned in this manner for 4 hours daily during the morning/early afternoon hours, for up to 3 days.
Usual Ambient Light
Participants assigned to the usual light arm will be exposed only to the usual lighting conditions of the hospital ward.
Usual Ambient Light
Across all arms, the usual ambient light in the inpatient room will not be modified.
For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions.
For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 12-14 inches from eye level with the on/off switch in the off position. The lamp will be positioned in this manner for 4 hours daily during the morning/early afternoon hours, for up to 3 days.
Interventions
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Bright Blue Light
Bright blue light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#132, Medium Blue) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Bright Full-Spectrum (White) Light
Bright full-spectrum (white) light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#211 0.9 ND) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Usual Ambient Light
Across all arms, the usual ambient light in the inpatient room will not be modified.
For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions.
For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 12-14 inches from eye level with the on/off switch in the off position. The lamp will be positioned in this manner for 4 hours daily during the morning/early afternoon hours, for up to 3 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh
UNKNOWN
Clinical and Translational Science Institute (CTSI), University of Pittsburgh
UNKNOWN
Rebecca E Kotcher, MD
OTHER
Responsible Party
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Rebecca E Kotcher, MD
T32 Postdoctoral Scholar
Principal Investigators
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Rebecca E Kotcher, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Presbyterian Hospital, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Marcantonio ER, Ngo LH, O'Connor M, Jones RN, Crane PK, Metzger ED, Inouye SK. 3D-CAM: derivation and validation of a 3-minute diagnostic interview for CAM-defined delirium: a cross-sectional diagnostic test study. Ann Intern Med. 2014 Oct 21;161(8):554-61. doi: 10.7326/M14-0865.
Auriemma CL, Taylor SP, Harhay MO, Courtright KR, Halpern SD. Hospital-Free Days: A Pragmatic and Patient-centered Outcome for Trials among Critically and Seriously Ill Patients. Am J Respir Crit Care Med. 2021 Oct 15;204(8):902-909. doi: 10.1164/rccm.202104-1063PP. No abstract available.
Nielsen S, Degenhardt L, Hoban B, Gisev N. A synthesis of oral morphine equivalents (OME) for opioid utilisation studies. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):733-7. doi: 10.1002/pds.3945. Epub 2015 Dec 22.
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.
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.
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.
Kotcher RE, Rosengart MR, La Colla L, Lin HS, Vogt KM, Xu Y, Neal MD. Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT): protocol for a randomised controlled trial in adult trauma inpatients with painful rib fractures. BMJ Open. 2025 Sep 5;15(9):e097462. doi: 10.1136/bmjopen-2024-097462.
Related Links
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Carex Day-Light Classic Plus Light Therapy Lamp
LEE Filter #132
LEE Filter #211 0.9ND
Maclocks Rise Freedom Extended Rolling Kiosk
Other Identifiers
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STUDY24040163
Identifier Type: -
Identifier Source: org_study_id
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