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

Trial Summary

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.

What data supports the idea that Light Exposure for Ehlers-Danlos Syndrome is an effective treatment?

The available research does not provide direct evidence supporting the effectiveness of Light Exposure for Ehlers-Danlos Syndrome. However, studies on similar conditions show some positive effects of LED therapy. For example, LED therapy has been shown to reduce inflammation in animal models of Achilles tendinitis and improve pain in clinical trials for joint disorders. Additionally, LED therapy has been effective in treating skin conditions and reducing inflammation in other disorders. These findings suggest potential benefits, but more specific research is needed for Ehlers-Danlos Syndrome. ^{1 2 3 4 5}

What safety data exists for Green LED Light Therapy?

The safety of LED light therapy, including Green LED Light, has been evaluated in various studies. A scoping review on LED therapy for synovial joint disorders included 15 clinical trials, indicating some positive effects but also variability in results. Safety data from studies on red LED light therapy, which is similar in nature, show that it is generally safe with mild adverse events like transient erythema and hyperpigmentation. No serious adverse events were reported, and the therapy is considered safe up to certain fluences depending on skin type. These findings suggest that LED light therapy, including Green LED Light, is generally safe, but further studies are needed to confirm its safety and efficacy specifically for Ehlers-Danlos Syndrome. ^{1 2 3 6 7}

Is Green LED light a promising treatment for Ehlers-Danlos Syndrome?

The provided research articles do not mention Green LED light or Green Light Therapy as a treatment for Ehlers-Danlos Syndrome. Therefore, there is no information available to suggest that it is a promising treatment for this condition. ^{8 9 10 11 12}

What is the purpose of this trial?

This trial investigates whether exposing people with hypermobile Ehlers Danlos Syndrome (hEDS) to green light can reduce their chronic pain. Participants will use a green light source regularly for a period of time. The green light is thought to help by changing how the brain processes pain signals, potentially improving their quality of life.

Research Team

Philip Noto, DO

Principal Investigator

NYITCOM

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

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

Anti-inflammatory effects of low-level light emitting diode therapy on Achilles tendinitis in rats. [2010]

2. England pubmed.ncbi.nlm.nih.gov

The use of LED therapy to treat synovial joints disorders: scoping review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Low-level red plus near infrared lights combination induces expressions of collagen and elastin in human skin in vitro. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Is light-emitting diode phototherapy (LED-LLLT) really effective? [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Biological effects of a new ultraviolet A1 prototype based on light-emitting diodes on the treatment of localized scleroderma. [2021]

6. England 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety of light emitting diode-red light on human skin: Two randomized controlled trials. [2022]

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

Use of complementary therapies for chronic pain management in patients with reported Ehlers-Danlos syndrome or hypermobility spectrum disorders. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The GoodHope Exercise and Rehabilitation (GEAR) Program for People With Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders. [2022]

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

Hypermobile Ehlers-Danlos syndromes: Complex phenotypes, challenging diagnoses, and poorly understood causes. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Are patients with hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder so different? [2022]

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

Physical therapy treatment of hypermobile Ehlers-Danlos syndrome: A systematic review. [2022]