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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRebecca E Kotcher, MD

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bright Blue Light
  • Bright Full-Spectrum (White) Light
  • Usual Ambient Light

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Rebecca E Kotcher, MD

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Institute of General Medical Sciences (NIGMS)

Collaborator

Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

Collaborator

Clinical and Translational Science Institute (CTSI), University of Pittsburgh

Collaborator