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

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.

Conditions

• Rib Fractures
• Pain, Acute

Interventions

DEVICE

Bright Blue Light

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.

DEVICE

Bright Full-Spectrum (White) Light

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.

DEVICE

Usual Ambient Light

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Rebecca E Kotcher, MD

  lead OTHER

Principal Investigators

• Rebecca E Kotcher, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-23

Primary Completion

2026-07-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations