Light Exposure for Ehlers-Danlos Syndrome

(LEEDS Trial)

Overseen By Philip Noto, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Disqualifiers: Serious mental illness, Color blindness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether green LED light can reduce pain for people with hypermobile Ehlers-Danlos Syndrome (hEDS), a condition causing chronic joint pain and affecting daily life. Participants will receive exposure to either green or white LED light for 1-2 hours daily over 10 weeks. The trial aims to determine if green light can improve pain and quality of life for those with hEDS. Individuals diagnosed with hEDS who experience significant pain not managed by current treatments might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore a novel approach to pain management for hEDS.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications as long as you have been on a stable regimen for at least 30 days before enrolling.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that green LED light is generally safe for people and may help with pain relief. Studies have found that people with migraines experienced fewer headaches after using green light. Another study showed it reduced pain and improved life quality for those with fibromyalgia. Green light has also been linked to lower inflammation in the body, which might help manage pain.

While these studies suggest benefits, they also indicate the treatment's safety. No major reports of harmful effects from green light have emerged. However, consider personal health and consult a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of green LED light for Ehlers-Danlos Syndrome because it offers a non-invasive approach that could complement or even provide an alternative to current treatments, which often include pain management techniques such as physical therapy, medications, and lifestyle changes. Unlike these traditional methods, green LED light aims to harness the therapeutic potential of specific light wavelengths to potentially reduce pain and improve quality of life without the need for drugs. This innovative approach could minimize side effects and offer a new avenue for relief that is both accessible and easy to administer.

What evidence suggests that this trial's treatments could be effective for Ehlers-Danlos Syndrome?

Research has shown that green LED light, which participants in this trial may receive, can help reduce pain and improve the quality of life for people with hypermobile Ehlers-Danlos Syndrome (hEDS). Studies have found that exposure to green light can boost the body's natural painkillers and decrease inflammation, potentially easing pain. Other research suggests that green light can reduce pain sensitivity and enhance overall comfort. These findings support the idea that green LED light might be useful in managing chronic pain linked to hEDS. Meanwhile, another group in this trial will receive white LED light as a sham comparator. ^{1 2 4 6 7}

Who Is on the Research Team?

Philip Noto, DO

Principal Investigator

NYITCOM

Are You a Good Fit for This Trial?

This trial is for adults over 18 with hypermobile Ehlers-Danlos Syndrome (hEDS) who have been in chronic pain despite medical treatment. Participants must speak English and have a stable pain management regimen, without starting new analgesic therapies within the last month. Those with serious mental illness, color blindness, uncorrected cataracts, or financial conflicts like pending litigation are excluded.

Inclusion Criteria

You have been diagnosed with hypermobile Ehlers-Danlos syndrome.

You have experienced pain that rates 5 or higher on a scale of 1 to 10 consistently for the past 10 weeks, and previous medical treatments have not helped to manage the pain.

Exclusion Criteria

Initiation of any new analgesic therapy within 30 days of enrollment (note: chronic therapy with a stable regimen maintained for at least 30 days prior to enrollment is permitted)

Serious mental illness, defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality or Major Depression Disorder

History of color blindness or uncorrected cataracts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants are exposed to either white or green LED light for 1-2 hours daily for 10 weeks to assess the impact on pain severity and quality of life.

10 weeks

Initial visit, 5-week visit, and 10-week visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Green LED light

Trial Overview The study is testing the effects of white and green LED light exposure on pain levels in hEDS patients. It aims to determine if this non-invasive intervention can reduce pain severity and improve quality of life by comparing patient-reported outcomes before and after light therapy sessions.

How Is the Trial Designed?

Group I: Green LED light Experimental Treatment 1 Intervention

Exposure to green LED light for 1-2 hours/day x 10 weeks

Group II: White LED light Placebo Group 1 Intervention

Exposure to white LED light for 1-2 hours/day x 10 weeks

Green LED light is already approved in United States for the following indications:

Approved in United States as Green Light Therapy for:

• Chronic pain in fibromyalgia and migraine
• Potential application in hypermobile Ehlers-Danlos Syndrome (hEDS)

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+

Published Research Related to This Trial

Low-level red (640 nm) and near-infrared (830 nm) LED light therapy significantly boosts the production of collagen and elastin in human dermal fibroblasts and skin tissues, indicating its potential as an effective anti-aging treatment.

The therapy also enhances ATP production in fibroblasts, which may contribute to the overall skin rejuvenation effects, making it a promising alternative for treating photo-aged skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level red plus near infrared lights combination induces expressions of collagen and elastin in human skin in vitro. Li, WH., Seo, I., Kim, B., et al.[2022]

Low-level LED therapy (880 nm) significantly reduced inflammation in a rat model of Achilles tendinitis, as evidenced by decreased inflammatory cell influx and lower levels of pro-inflammatory cytokines like IL-1 beta, IL-6, and TNF-alpha.

The therapy was effective when applied starting 12 hours after tendinitis induction, suggesting that LED treatment can enhance tissue response and reduce inflammation in tendon injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effects of low-level light emitting diode therapy on Achilles tendinitis in rats. Xavier, M., David, DR., de Souza, RA., et al.[2010]

Patients with hypermobile Ehlers-Danlos syndrome (hEDS) experience more severe pain, motricity problems, and bleeding compared to those with hypermobile spectrum disorder (HSD), but both groups have similar prevalence of extra-articular manifestations like bone fragility and neuropathic pain.

After coordinated physical therapy, over 50% of patients from both hEDS and HSD reported improvement in their condition, suggesting that these disorders may be treated similarly and could be considered as a single entity in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are patients with hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder so different? Aubry-Rozier, B., Schwitzguebel, A., Valerio, F., et al.[2022]

The GoodHope Exercise and Rehabilitation (GEAR) program is a new approach designed to help individuals with Ehlers-Danlos Syndromes (EDS) and Generalized Hypermobility Spectrum Disorders (G-HSD) by focusing on reducing pain, improving function, and enhancing self-management skills.

This program includes a combination of exercise therapy, education, and community support, and aims to address a wider range of EDS subtypes beyond just hypermobile EDS, with ongoing data collection to refine its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GoodHope Exercise and Rehabilitation (GEAR) Program for People With Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders. Mittal, N., Santa Mina, D., Buryk-Iggers, S., et al.[2022]

This scoping review analyzed 47 studies on LED therapy for synovial joint disorders, including 15 clinical trials, and found some positive effects on cell proliferation and pain reduction, but results varied widely due to differences in device parameters and dosimetry.

The review highlighted the need for future research to address fundamental questions about LED therapy's effectiveness, such as optimal penetration depth and treatment duration, to better understand its impact on synovial joint conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of LED therapy to treat synovial joints disorders: scoping review. Coracini, CA., Dos Santos Soares, F., Bertolini, GRF.[2022]

LED-based UVA1 phototherapy, with a narrower spectral range, shows similar or improved efficacy compared to conventional UVA1 treatments for localized scleroderma, particularly in reducing myofibroblasts and collagen levels.

This new LED technology offers advantages in terms of safety and patient comfort, including less heat generation and shorter treatment times, making it a promising alternative to traditional UVA1 light sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological effects of a new ultraviolet A1 prototype based on light-emitting diodes on the treatment of localized scleroderma. Arndt, S., Lissner, C., Unger, P., et al.[2021]

Physiotherapy techniques have been shown to significantly improve pain and proprioception in patients with hypermobile type Ehlers-Danlos syndrome (hEDS), based on a systematic review of 6 randomized controlled trials involving 20 to 57 patients each.

Despite the variability in interventions and a lack of robust studies, the review indicates that physiotherapy can enhance the quality of life and functional exercise capacity in hEDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy treatment of hypermobile Ehlers-Danlos syndrome: A systematic review. Reychler, G., De Backer, MM., Piraux, E., et al.[2022]

In two phase I clinical trials involving 115 healthy participants, LED-red light (LED-RL) was found to be safe at fluences up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasians, with only mild adverse events reported.

The study identified that dose-limiting adverse events, such as blistering, occurred at higher fluences, indicating that LED-RL may have different effects based on skin type, which is important for guiding future therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of light emitting diode-red light on human skin: Two randomized controlled trials. Jagdeo, J., Nguyen, JK., Ho, D., et al.[2022]

A survey of over 500 individuals with Ehlers-Danlos Syndromes (EDS) and Hypermobility Spectrum Disorders (HSD) revealed that a significant number (70-92%) use common pain management therapies like non-steroidal anti-inflammatory drugs, acetaminophen, opioids, and physical therapy.

Participants rated opioids, physical therapy, and marijuana as the most effective treatments for pain relief, with 10-24% finding them extremely helpful, highlighting the need for healthcare providers to consider these widely used non-prescribed therapies in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of complementary therapies for chronic pain management in patients with reported Ehlers-Danlos syndrome or hypermobility spectrum disorders. Demes, JS., McNair, B., Taylor, MRG.[2021]

Ehlers-Danlos syndromes (EDS) are a group of heritable connective tissue disorders with various subtypes, characterized by joint hypermobility and tissue fragility, with the hypermobile type (hEDS) being the most common but having an unknown genetic basis.

The variability in symptoms and severity of hEDS may be influenced by factors such as age, gender, and lifestyle, highlighting the complexity of its clinical presentation and the need for further research into its underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypermobile Ehlers-Danlos syndromes: Complex phenotypes, challenging diagnoses, and poorly understood causes. Gensemer, C., Burks, R., Kautz, S., et al.[2023]

This study investigates the safety of high-fluence LED-red light (HF-LED-RL) phototherapy at doses of 480 and 640 J/cm2 in healthy Caucasian non-Hispanic individuals, aiming to establish a safety profile for this treatment.

The trial is designed as a single-blind, dose-escalation study with up to 60 participants, which will help determine the maximum tolerated dose and assess potential cutaneous effects, contributing to new treatment options based on race and ethnicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-blind, dose-escalation, phase I study of high-fluence light-emitting diode-red light on Caucasian non-Hispanic skin: study protocol for a randomized controlled trial. Wang, EB., Kaur, R., Nguyen, J., et al.[2022]

Low level light therapy (LLLT) using specific wavelengths of LED light (633 nm and 830 nm) has been shown to effectively enhance wound healing and reduce pain and inflammation, supported by both animal and human studies.

LED-LLLT can significantly improve outcomes for non-healing wounds and accelerate healing in normal wounds, making it a promising adjunct treatment alongside traditional surgical and nonsurgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is light-emitting diode phototherapy (LED-LLLT) really effective? Kim, WS., Calderhead, RG.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1526590022004370

Green Light Exposure Elicits Anti-inflammation ... We showed that green light increases endogenous opioid levels while lessening synaptic plasticity and neuroinflammation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8034831/

Evaluation of Green Light Exposure on Headache ... Conclusions regarding pain medications reduction with GLED exposure were not possible. No side effects of light therapy were reported. None of the patients in ...

3. mdpi.com mdpi.com/2227-9059/12/9/2005

Green Light Exposure Reduces Primary Hyperalgesia and ... These findings suggest that GLED exposure reduces primary hyperalgesia in OA, potentially by lowering proinflammatory cytokines, and indicate sex differences.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7861466/

Green Light Exposure Improves Pain and Quality of Life in ... We demonstrated that exposure to green light-emitting diodes (GLED) for 8 hours/day for 5 days resulted in antinociception and reversal of thermal and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05561270

Light Exposure on Pain in Hypermobile Ehlers-Danlos ... Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32903062/

Evaluation of green light exposure on headache frequency ... Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine.

7. researchgate.net researchgate.net/publication/347131428_Green_Light_Exposure_Improves_Pain_and_Quality_of_Life_in_Fibromyalgia_Patients_A_Preliminary_One-Way_Crossover_Clinical_Trial

Green Light Exposure Improves Pain and Quality of Life in ... Clinical and preclinical studies demonstrated that green light-emitting diodes (LEDs) were particularly efficacious for pain relief in rats after nerve injury ...