Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT)

Rebecca E Kotcher, MD

Status: Enrolling

Conditions: Pain, Acute; Rib Fractures

Treatments: Device: Bright Full-Spectrum (White) Light; Device: Usual Ambient Light; Device: Bright Blue Light

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06626334

T32GM075770 (U.S. NIH Grant/Contract)

STUDY24040163

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

• 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

  • 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Bright Blue Light

Experimental group

Description:

The light therapy lamp will be covered with a filter selecting for short wavelength blue light (peak 442 nm, intensity \~1400 lux).

Treatment:

Device: Usual Ambient Light

Device: Bright Blue Light

Bright Full-Spectrum (White) Light

Active Comparator group

Description:

The light therapy lamp will be covered with a filter modifying only the light's intensity (\~1400 lux).

Treatment:

Device: Usual Ambient Light

Device: Bright Full-Spectrum (White) Light

Usual Ambient Light

Other group

Description:

Participants assigned to the usual light arm will be exposed only to the usual lighting conditions of the hospital ward.

Treatment:

Device: Usual Ambient Light