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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Rebecca E Kotcher, MD
Study ID
NCT06626334
Status
Recruiting
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Conditions

  • Pain, Acute
  • Rib Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bright Blue Light — DEVICE
    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) Light — DEVICE
    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 Light — DEVICE
    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 Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Active Comparator: Bright Full-Spectrum (White) Light
    The light therapy lamp will be covered with a filter modifying only the light's intensity (\~1400 lux).
  • Other: 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 Measure

Chest wall pain intensity, with incentive spirometer use [ Time Frame: Up to 72 hours (assessed twice daily) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Presbyterian Hospital, University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Rebecca E Kotcher, MD
[email protected]
412-647-7243
Rebecca E Kotcher, MD (PRINCIPAL_INVESTIGATOR)
Matthew D Neal, MD (SUB_INVESTIGATOR)
Keith M Vogt, MD, PhD (SUB_INVESTIGATOR)
Yan Xu, PhD (SUB_INVESTIGATOR)
Luca La Colla, MD, MSHI (SUB_INVESTIGATOR)
Rida Zakar, MD (SUB_INVESTIGATOR)
Abiha Abdullah, MD (SUB_INVESTIGATOR)

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By research site
Presbyterian Hospital, University of Pittsburgh Medical Center· Pittsburgh, PA

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