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?

This trial explores whether blue light therapy, a form of phototherapy, can reduce pain and inflammation in individuals with painful rib fractures. Researchers will compare blue light therapy with white light therapy and regular hospital lighting to determine which is most effective in easing pain, particularly during deep breathing. Participants will receive their assigned light treatment for four hours daily while continuing their standard pain treatments. Adults admitted to a specific hospital with painful rib fractures who can provide informed consent are suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance pain management for future patients.

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.

What prior data suggests that blue light therapy is safe for treating rib fractures?

Research shows that blue light therapy is generally easy for people to handle. Previous studies have explored its use for easing pain and swelling, suggesting that blue light therapy is a safe, non-medication option. No reports of serious side effects have emerged.

Participants in these studies did not experience major problems, and the therapy caused no harm. It is considered low-risk and affordable, making it a good choice for managing rib fracture pain.

White light therapy, another option in the trial, is also well-known and often used in light therapy. It is considered safe. Both light therapies are non-invasive, meaning they do not enter the body, which reduces the chance of complications compared to other treatments. Overall, both therapies have been shown to be safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Blue light therapy is unique because it offers a non-invasive approach to aiding the healing of rib fractures, which typically rely on pain management and supportive care. Unlike traditional methods, this treatment uses a specific wavelength of blue light (peak 442 nm) to potentially accelerate recovery by influencing cellular processes under the skin. Researchers are excited about this technique because it could provide a quicker, less painful recovery for patients without the side effects associated with medications. The use of light therapy could revolutionize how fractures are managed, reducing reliance on conventional pain relief methods.

What evidence suggests that blue light therapy is effective for rib fracture pain?

Research has shown that blue light therapy might help reduce pain and swelling in people with broken ribs. In this trial, participants may receive bright blue light therapy, which studies suggest can act as an anti-inflammatory, potentially relieving pain from injuries. This therapy is non-invasive, requiring neither surgery nor medication. Although researchers are still gathering solid evidence on its effectiveness specifically for rib fractures, early results appear promising. Bright blue light therapy could offer a low-risk option to help manage pain alongside standard treatments. ^{1 2 3 5 6}

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+

Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

Collaborator

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

Collaborator

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12414232/

Blue Light as an Anti-inflammatory and Analgesic Strategy in ... We propose blue light therapy as a low-risk, low-cost, non-pharmacological adjunct in rib fracture management, hypothesising that it will offer ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e097462

Blue Light as an Anti-inflammatory and Analgesic Strategy ... Bright light exposures will be administered for 4 consecutive hours daily for up to 3 days. The primary outcome will be any measurable changes in chest wall ...

3. trialx.com trialx.com/clinical-trials/listings/303807/blue-light-as-an-anti-inflammatory-and-analgesic-strategy-in-thoracic-trauma/

Blue Light As an Anti-inflammatory and Analgesic Strategy ... 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 ...

4. withpower.com withpower.com/trial/phase-rib-fractures-9-2024-6855b

Blue Light Therapy for Rib Fractures (BLAASTT Trial) The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures.

5. trial.medpath.com trial.medpath.com/clinical-trial/964c276569e0b3d7/nct06626334-blue-light-anti-inflammatory-analgesic-thoracic-trauma

Blue Light as an Anti-inflammatory and Analgesic Strategy in ... The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures.

6. researchgate.net researchgate.net/publication/395315627_Blue_Light_as_an_Anti-inflammatory_and_Analgesic_Strategy_in_Thoracic_Trauma_BLAASTT_protocol_for_a_randomised_controlled_trial_in_adult_trauma_inpatients_with_painful_rib_fractures

protocol for a randomised controlled trial in adult trauma ... Our findings suggest that chest wall anesthetic blocks are a safe and effective therapy for pain caused by rib fractures. At admission, the ...