Blue Light As an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma
- Conditions
- Rib FracturesPain, Acute
- Interventions
- Device: Bright Blue LightDevice: Bright Full-Spectrum (White) LightDevice: Usual Ambient Light
- Registration Number
- NCT06626334
- Lead Sponsor
- Rebecca E Kotcher, MD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
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Mechanical ventilation* or non-invasive positive pressure ventilation administered for respiratory insufficiency prior to the time of informed consent
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Delirium (positive CAM screening) at the time of informed consent
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Ocular trauma, which may interfere with the mechanism of action
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Traumatic brain injury, which may interfere with the mechanism of action
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Splenectomy upon admission or history of splenectomy, which may interfere with the mechanism of action
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History of significant ocular dysfunction** (i.e., macular degeneration, glaucoma, cataracts), which may interfere with the mechanism of action
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History of cataract surgery, due to the possibility of blue light filtering intraocular lens placement
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History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bright Blue Light 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 Usual Ambient Light The 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 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 Usual Ambient Light The light therapy lamp will be covered with a filter modifying only the light's intensity (\~1400 lux). Usual Ambient Light Usual Ambient Light Participants assigned to the usual light arm will be exposed only to the usual lighting conditions of the hospital ward.
- Primary Outcome Measures
Name Time Method Chest wall pain intensity, with incentive spirometer use 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.
- Secondary Outcome Measures
Name Time Method Intensive care unit-free days 30 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.
Rev-Erb alpha expression Up to 72 hours (blood samples collected daily) Rev-Erb alpha is a circadian clock protein that will be used as a surrogate for circadian clock activation. Rev-Erb alpha expression will be quantified using Western Blot on blood samples collected each morning for up to 4 collections over the course of active study participation. Rev-erb alpha expression over time will be compared across study arms.
IL-6 concentration Up to 72 hours (blood samples collected daily) Pro-inflammatory cytokine IL-6 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-6 concentration over time will be compared across study arms.
TNF-alpha concentration Up to 72 hours (blood samples collected daily) Pro-inflammatory cytokine TNF-alpha concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. TNF-alpha concentration over time will be compared across study arms.
IL-10 concentration Up to 72 hours (blood samples collected daily) Anti-inflammatory cytokine IL-10 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-10 concentration over time will be compared across study arms.
Opioid requirements Up to 72 hours (calculated daily) 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.
Hospital-free days 30 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.
Incidence of in-hospital delirium At 72 hours or date of discharge (assessed daily) 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.
Incidence of pulmonary complications 30 days 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.
Chest wall pain intensity, at rest Up to 72 hours (assessed twice daily) 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.
Trial Locations
- Locations (1)
Presbyterian Hospital, University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States