Rib FracturesBLAASTTNCT06626334
Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
A study testing Bright Blue Light, Bright Full-Spectrum (White) Light and Usual Ambient Light in people with Rib Fractures and Pain, Acute, run by Rebecca E Kotcher, MD at 1 site in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Pain, Acute
- What is being tested?
- Bright Blue Light, Bright Full-Spectrum (White) Light and Usual Ambient Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Presbyterian Hospital, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma: A Randomized Controlled Trial in Adults With Rib Fractures
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?
Read more
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.
- Conditions
- Rib Fractures, Pain, Acute
- Being tested
- Bright Blue Light, Bright Full-Spectrum (White) Light, Usual Ambient Light
- Keywords
- Light Therapy, Blue Light Therapy, Pain Control, Analgesia, Immunomodulation, Bright Light Therapy
- Medical subject headings
- Rib Fractures, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Blue LightDevice
Also called Carex Day-Light Classic Plus Light Therapy Lamp, CCFDL93011, LEE Filters
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) LightDevice
Also called Carex Day-Light Classic Plus Light Therapy Lamp, CCFDL93011, LEE Filters
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 LightDevice
Also called Carex Day-Light Classic Plus Light Therapy Lamp, CCFDL93011
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.
| Study group | Role | What they receive |
|---|---|---|
| Bright Blue Light | Experimental | The light therapy lamp will be covered with a filter selecting for short wavelength blue light (peak 442 nm, intensity ~1400 lux). Receives: Device: Bright Blue Light; Device: Usual Ambient Light |
| Bright Full-Spectrum (White) Light | Active comparator | The light therapy lamp will be covered with a filter modifying only the light's intensity (~1400 lux). Receives: Device: Bright Full-Spectrum (White) Light; Device: Usual Ambient Light |
| Usual Ambient Light | Other | Participants assigned to the usual light arm will be exposed only to the usual lighting conditions of the hospital ward. Receives: Device: Usual Ambient Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours (assessed twice daily)
Secondary outcomes (6)
Intensive care unit-free days
Intensive care unit-free days at 30 days is calculated as 30 minus the number of days spent in an intensive care unit. Participants with death occurring within 30 days of enrollment will be assigned 0 ICU-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in ICU-free days will be compared across study arms.
Measured: 30 days
Opioid requirements
Daily opioid requirements as quantified by standardized oral morphine equivalents (OME) will be calculated daily during up to 72 hours of active study participation using opioid use data abstracted from the electronic medical record and a comprehensive OME conversion table. Opioid requirements over time will be compared across study arms.
Measured: Up to 72 hours (calculated daily)
Chest wall pain intensity, at rest
Chest wall pain intensity at rest will be measured using the Numerical Rating Scale, elicited when the participant is at rest. 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 assessed at baseline for the purpose of eligibility screening. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation, including twice daily during up to three intervention days and once on the morning following the final intervention day. Pain scale values over time will be compared across study arms.
Measured: Up to 72 hours (assessed twice daily)
Hospital-free days
Hospital-free days at 30 days is calculated as 30 minus the number of days spent in an acute-care hospital, long-term acute care hospital (LTACH), or in an emergency department (ED). Participants with death occurring within 30 days of enrollment will be assigned 0 hospital-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in hospital-free days will be compared across study arms.
Measured: 30 days
Incidence of in-hospital delirium
The presence or absence of delirium will be assessed using the 3-minute diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM). Based on the bedside assessment, a published algorithm deems the participant either positive or negative for delirium. The assessment will then be administered at multiple timepoints during the 72 hour period of active study participation, including daily on each intervention day (study days 1-3) and on the morning following the final intervention day (study day 4 or day of discharge). The incidence of delirium within this timeframe will be compared across study arms.
Measured: At 72 hours or date of discharge (assessed daily)
Incidence of pulmonary complications
Pulmonary complications are defined by a composite outcome (clinical pneumonia OR respiratory insufficiency requiring non-invasive positive pressure ventilation OR respiratory failure requiring mechanical ventilation). This dichotomous (yes/no) outcome will be assessed for each participant by electronic medical record review at 30 days post-enrollment. The incidence of pulmonary complications within this timeframe will be compared across study arms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start23 Oct 2024
- Primary completion25 Apr 2026
- Study completion1 Jun 2026
Why it stopped: Recruitment challenges/Insufficient resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca E Kotcher, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh, Clinical and Translational Science Institute (CTSI), University of Pittsburgh
- Responsible party
- Sponsor-investigator, Rebecca E Kotcher, MD, University of Pittsburgh
- Investigators
- Rebecca E Kotcher, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626334
- Sponsor's protocol ID
- STUDY24040163
- Other IDs
- T32GM075770
- Acronym
- BLAASTT
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25329203Auriemma 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.
PubMed 34319848Nielsen 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.
PubMed 26693665Yuan 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.
PubMed 27114521Lewis 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.
PubMed 29727369Griepentrog 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.
PubMed 31379019Kotcher 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.
PubMed 40912706
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma: A Randomized Controlled Trial in Adults With Rib Fractures
- ClinicalTrials.gov ID
- NCT06626334
- Acronym / sponsor ID
- BLAASTT / STUDY24040163
- Conditions
- Rib Fractures, Pain, Acute
- Keywords
- Light Therapy, Blue Light Therapy, Pain Control, Analgesia, Immunomodulation, Bright Light Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges/Insufficient resources
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rebecca E Kotcher, MDUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh, Clinical and Translational Science Institute (CTSI), University of Pittsburgh
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bright Blue Light | Experimental | Device: Bright Blue Light, Device: Usual Ambient LightThe 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 comparator | Device: Bright Full-Spectrum (White) Light, Device: Usual Ambient LightThe light therapy lamp will be covered with a filter modifying only the light's intensity (~1400 lux). |
| Usual Ambient Light | Other | Device: Usual Ambient LightParticipants assigned to the usual light arm will be exposed only to the usual lighting conditions of the hospital ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Blue LightAlso: Carex Day-Light Classic Plus Light Therapy Lamp, CCFDL93011, LEE FiltersBright 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. | Device | Bright Blue Light |
| Bright Full-Spectrum (White) LightAlso: Carex Day-Light Classic Plus Light Therapy Lamp, CCFDL93011, LEE FiltersBright 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. | Device | Bright Full-Spectrum (White) Light |
| Usual Ambient LightAlso: Carex Day-Light Classic Plus Light Therapy Lamp, CCFDL93011Across 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. | Device | Bright Blue Light, Bright Full-Spectrum (White) Light, Usual Ambient Light |
Primary outcome
Chest wall pain intensity, with incentive spirometer use
Time frame: Up to 72 hours (assessed twice daily)
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.
6 secondary outcomes
Intensive care unit-free days
Time frame: 30 days
Opioid requirements
Time frame: Up to 72 hours (calculated daily)
Chest wall pain intensity, at rest
Time frame: Up to 72 hours (assessed twice daily)
Hospital-free days
Time frame: 30 days
Incidence of in-hospital delirium
Time frame: At 72 hours or date of discharge (assessed daily)
Incidence of pulmonary complications
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Recruitment challenges/Insufficient resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 25329203Marcantonio 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.
- Background: PubMed 34319848Auriemma 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.
- Background: PubMed 26693665Nielsen 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.
- Background: PubMed 27114521Yuan 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.
- Background: PubMed 29727369Lewis 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.
- Background: PubMed 31379019Griepentrog 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.
- Derived from this study: PubMed 40912706Kotcher 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.
- Carex Day-Light Classic Plus Light Therapy LampLink provided by the sponsor.
- LEE Filter #132Link provided by the sponsor.
- LEE Filter #211 0.9NDLink provided by the sponsor.
- Maclocks Rise Freedom Extended Rolling KioskLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca E Kotcher, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Blue Light, Bright Full-Spectrum (White) Light and Usual Ambient Light in people with Rib Fractures and Pain, Acute, run by Rebecca E Kotcher, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment challenges/Insufficient resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest wall pain intensity, with incentive spirometer use (time frame: Up to 72 hours (assessed twice daily)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06626334, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.