Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
BLAASTT
2 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedStudy Start
First participant enrolled
October 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
March 4, 2026
October 1, 2025
1.7 years
October 1, 2024
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chest wall pain intensity, with incentive spirometer use
Chest wall pain intensity with deep breathing will be measured using the Numerical Rating Scale, elicited when the participant is taking a full tidal volume breath using their incentive spirometer. The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation including twice daily on up to three intervention days (study days 1-3) and once on the morning following the final intervention day (study day 4 or day of discharge). Pain scale values over time will be compared across study arms.
Up to 72 hours (assessed twice daily)
Secondary Outcomes (10)
Intensive care unit-free days
30 days
Rev-Erb alpha expression
Up to 72 hours (blood samples collected daily)
IL-6 concentration
Up to 72 hours (blood samples collected daily)
TNF-alpha concentration
Up to 72 hours (blood samples collected daily)
IL-10 concentration
Up to 72 hours (blood samples collected daily)
- +5 more secondary outcomes
Study Arms (3)
Bright Blue Light
EXPERIMENTALThe light therapy lamp will be covered with a filter selecting for short wavelength blue light (peak 442 nm, intensity \~1400 lux).
Bright Full-Spectrum (White) Light
ACTIVE COMPARATORThe light therapy lamp will be covered with a filter modifying only the light's intensity (\~1400 lux).
Usual Ambient Light
OTHERParticipants assigned to the usual light arm will be exposed only to the usual lighting conditions of the hospital ward.
Interventions
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rebecca E Kotcher, MDlead
- National Institutes of Health (NIH)collaborator
- National Institute of General Medical Sciences (NIGMS)collaborator
- Department of Anesthesiology & Perioperative Medicine, University of Pittsburghcollaborator
- Clinical and Translational Science Institute (CTSI), University of Pittsburghcollaborator
Study Sites (1)
Presbyterian Hospital, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (7)
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.
PMID: 25329203BACKGROUNDAuriemma 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.
PMID: 34319848BACKGROUNDNielsen 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.
PMID: 26693665BACKGROUNDYuan 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.
PMID: 27114521BACKGROUNDLewis 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.
PMID: 29727369BACKGROUNDGriepentrog 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.
PMID: 31379019BACKGROUNDKotcher 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.
PMID: 40912706DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca E Kotcher, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This trial is unblinded due to the nature of a lighting intervention, in which participants and investigators will know which intervention is being administered.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- T32 Postdoctoral Scholar
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
October 23, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
March 4, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be made available beginning 12 months and ending 36 months following article publication. Data will be available to those requesting the data for 1 year after proposal approval.
- Access Criteria
- Data will be shared with those researchers who provide a methodologically sound proposal. Only those data necessary to achieve the aims in the approved proposal will be shared. De-identified study data as well as the Study Protocol, Statistical Analysis Plan, and Analytic Code will be made available as appropriate. Proposals should be directed to the corresponding author (kotcherre@upmc.edu) and will undergo approval by the study team.
De-identified study data may be provided to researchers at the University of Pittsburgh, other institutions and/or federal repositories for the purposes of research collaboration. Sharing will be completed under an approved sharing agreement. In addition to de-identified study data, the Study Protocol, Statistical Analysis Plan, and Analytic Code will be made available to those researchers with an approved sharing agreement.