What side effects are associated with this type of intervention?

Green light exposure is being studied for its potential to alleviate pain in individuals with hypermobile Ehlers-Danlos Syndrome (hEDS). While specific side effects of green light exposure are not detailed, similar light-based therapies generally have minimal adverse effects. For instance, red light therapy, another non-invasive light treatment, has shown no adverse events in clinical studies. Therefore, it is reasonable to infer that green light exposure may also have a favorable safety profile with minimal side effects, making it a promising option for pain management in hEDS patients.

What prior FDA approvals exist?

The provided context does not mention any specific FDA-approved treatments for Ehlers-Danlos Syndrome (EDS). The trial on green light exposure for pain perception modulation in hypermobile EDS is an investigational approach and does not reference any prior FDA-approved treatments. Generally, treatments for EDS focus on managing symptoms and may include pain management strategies, physical therapy, and sometimes surgical interventions.

What other types of research exist?

Promising novel alternatives to Green Light Exposure for pain perception modulation in Ehlers-Danlos Syndrome patients include: 1) Mindfulness-Based Stress Reduction (MBSR), which has shown variation in treatment outcomes for chronic pain conditions; 2) Yoga, which has demonstrated benefits for functional ability, pain, and psychosocial outcomes in musculoskeletal conditions; and 3) Hypnosis, which is effective for managing chronic pain. These alternatives offer non-pharmacologic approaches that may improve quality of life for EDS patients.

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Light Therapy

Light Exposure for Ehlers-Danlos Syndrome (LEEDS Trial)

N/A

Recruiting

Led By Philip Noto, DO

Research Sponsored by New York Institute of Technology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve exposure to LED lights, side effects may be minimal but could include eye strain or headache due to light sensitivity. There's no mention of severe side effects as it's a non-pharmacological treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in pain intensity as measured by subject-reported numeric pain severity (NPS) rating

Secondary study objectives

Changes in dosage of pain medication used

Changes in frequency of pain medication usage

Health-related quality of life as measured by subject-reported Short-Form 36 Health Survey (SF-36)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Green LED lightExperimental Treatment1 Intervention

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

Group II: White LED lightPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Green LED light

2017

N/A

~60

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ehlers-Danlos Syndrome (EDS) focus on managing symptoms such as pain, joint instability, and skin fragility. Physical therapy is often used to strengthen muscles and improve joint stability, while pain management may involve medications like acetaminophen or NSAIDs. The trial on green light exposure for pain in hypermobile EDS (hEDS) suggests a focus on non-invasive, alternative therapies that modulate pain perception by influencing neurological pathways. Effective pain management is crucial for EDS patients as it can significantly enhance their quality of life and daily functioning, addressing one of the most debilitating aspects of the syndrome.

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