Recruiting

Light Exposure

Sponsor:

New York Institute of Technology

Code:

NCT05561270

Conditions

Ehlers-Danlos Syndrome

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

White LED light

Green LED light

Study Details

Brief summary:

Chronic pain is a major complaint among many individuals living with hypermobile Ehlers Danlos Syndrome (hEDS) and may have a severe impact on quality of life and activities of daily living. Given the complexity of the disease's pathophysiology, effective treatments are limited. This investigation will examine the impacts of green light exposure on subject-reported pain severity and symptoms. Knowing whether this intervention can improve pain and quality of life in this population may offer valuable guidance to clinicians who treat hEDS patients and to hEDS patients themselves.

Conditions

Ehlers-Danlos Syndrome

Pain, Chronic

Study ID

NCT05561270

Start date

Nov 21, 2022

Status verified date

May, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years of age or older and able to speak, read, and understand English
2. Diagnosed with hEDS
3. Average numeric pain score of 5 out of 10 or greater over the 10 weeks prior to enrolling in the study and failure of medical therapy to control the pain

Exclusion Criteria:

1. 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)
2. Serious mental illness, defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality or Major Depression Disorder
3. History of color blindness or uncorrected cataracts
4. Receiving remuneration, or litigation pending, for their medical conditions

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

sham comparator: White LED light

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

experimental: Green LED light

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

Interventions

White LED light

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

Green LED light

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

Primary outcome measure

  • Changes in pain intensity as measured by subject-reported numeric pain severity (NPS) rating [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Locations

New York Institute of Technology College of Osteopathic Medicine

Recruiting

Old Westbury, New York, United States, 11568

Contacts

Philip Noto, DO

pnoto@nyit.edu

Principal Investigator:

Philip Noto, DO

More Information

Sponsor

New York Institute of Technology

Last update posted

May 6, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2024-05-06.