Blue Light Therapy for Rib Fractures

(BLAASTT Trial)

Overseen By Rebecca E Kotcher, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rebecca E Kotcher, MD

Disqualifiers: Mechanical ventilation, Delirium, Ocular trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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. * 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems that participants will continue with standard pain treatments alongside the light therapy.

How is Blue Light Therapy different from other treatments for rib fractures?

Blue Light Therapy is unique because it uses light to potentially aid in healing rib fractures, unlike traditional treatments that often focus on pain management and physical support. This approach is non-invasive and does not rely on medication, which may offer an alternative for those seeking non-drug options. ^{1 2 3 4 5}

Who Is on the Research Team?

Rebecca E Kotcher, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults with painful rib fractures may join this trial. They must be hospitalized and willing to undergo light therapy alongside standard pain treatments. However, individuals who might experience confusion (delirium) due to hospitalization or have conditions that could interfere with the study are not eligible.

Inclusion Criteria

Greater than or equal to 1 acute rib fracture

I am mentally capable of understanding and consenting to treatment.

I experience pain from rib fractures that scores 4 or more out of 10 when I breathe deeply.

Exclusion Criteria

Delirium (positive CAM screening) at the time of informed consent

I have had an eye injury that could affect treatment.

I have had a brain injury that could affect my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive assigned light therapy for 4 hours during the morning/early afternoon for up to 3 days while in the hospital

3 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up phone call at 30 days

30 days

1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

• Blue Light

Trial Overview The trial is testing if bright blue light can reduce pain and inflammation when added to regular pain management for rib fracture patients. It compares blue light, white light, and usual lighting over three days, measuring pain levels, delirium signs, heart rate changes, and blood markers of inflammation.

How Is the Trial Designed?

Group I: Usual Ambient Light Experimental Treatment 1 Intervention

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

Group II: Bright Blue Light Experimental Treatment 2 Interventions

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

Group III: Bright Full-Spectrum (White) Light Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Rebecca E Kotcher, MD

Lead Sponsor

Trials

1

Recruited

80+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 252 patients with blunt thoracic trauma, a higher number of rib fractures was associated with increased morbidity and longer hospital stays, indicating that rib fractures can complicate recovery.

Patients with rib fractures who also experienced hemothorax had significantly more rib fractures compared to those without hemothorax, suggesting that the presence of rib fractures may indicate more severe injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the presence of rib fracture on mortality and morbidity in blunt thoracic traumas. Kozanlı, F., Güler, Ö.[2023]

This systematic review aims to evaluate how non-pharmacological therapies, such as physical therapy or other interventions, impact pain relief and physical function in adults suffering from rib fractures.

The findings will help clarify the effectiveness of these non-drug treatments, potentially guiding better management strategies for patients with rib fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of non-pharmacological interventions for pain and physical function in adults with rib fractures: a systematic review protocol. Weinberg, B., Roos, R., van Aswegen, H.[2019]

The Revised Intensity Battle Score (RIBS) was validated in a study of 1,493 adult patients with rib fractures, showing strong predictive ability for complications, particularly with an area under the curve (AUC) of 0.735 for any complication and 0.771 for more than 7 ventilator days.

RIBS outperformed other scoring systems in predicting outcomes, suggesting it could be a valuable tool for triaging patients to receive more intensive care, such as direct ICU admission and aggressive respiratory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of novel Revised Intensity Battle (RIB) Score and comparison of static rib fracture scoring systems. Buchholz, CJ., D'Aquila, ML., Lollar, DI.[2023]

In a study of 86 patients with rib fractures and atelectasis after thoracic trauma, those who underwent pulmonary reexpansion showed significant improvements in blood oxygen saturation and pulmonary function compared to those who did not.

Patients in the reexpansion group experienced fewer secondary infections and reported higher satisfaction with their quality of life three months post-discharge, although this treatment was associated with higher hospitalization costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the therapeutic effect and prognosis in 86 cases of rib fractures and atelectasis. Yin, D., Lu, J., Wang, J., et al.[2021]

A study of 63 patients with thoracic trauma found that the optimal time for MSCT examination of subtle rib fractures is between the third and fifth week after the injury, as this period reveals significant pathophysiological changes.

The research indicated that rib fractures may not be consistently diagnosed in the first week post-trauma, highlighting the importance of timing in imaging for accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MSCT optimal examination time for unconspicuous rib fracture]. Zhang, MG., Kong, JM., Zheng, Y., et al.[2016]

Citations

1. Turkey pubmed.ncbi.nlm.nih.gov

Effect of the presence of rib fracture on mortality and morbidity in blunt thoracic traumas. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of non-pharmacological interventions for pain and physical function in adults with rib fractures: a systematic review protocol. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

External validation of novel Revised Intensity Battle (RIB) Score and comparison of static rib fracture scoring systems. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Analysis of the therapeutic effect and prognosis in 86 cases of rib fractures and atelectasis. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[MSCT optimal examination time for unconspicuous rib fracture]. [2016]