Light Exposure on Pain in Hypermobile Ehlers-Danlos Syndrome

NCT05561270 | Recruiting

• 1 other identifier: BHS-1755
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Subjects will report pain intensity daily as a numeric pain severity (NPS) rating, a subjective pain scale ranging from 0 (no pain) to 10 (most severe pain)

  10 weeks

Secondary Outcomes (7)

• Qualitative changes in pain as measured by Short-Form McGill Pain Questionnaire (SFMPQ)

  10 weeks

• Changes in frequency of pain medication usage

  10 weeks

• Changes in dosage of pain medication used

  10 weeks

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

  10 weeks

• Insomnia as measured by subject-reported Athens Insomnia Scale

  10 weeks

Study Arms (2)

White LED light

SHAM COMPARATOR

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

Device: White LED light

Green LED light

EXPERIMENTAL

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

Device: Green LED light

Interventions

White LED light DEVICE

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

White LED light

Green LED light DEVICE

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

Green LED light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older and able to speak, read, and understand English
• Diagnosed with hEDS
• 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

You may not qualify if:

• 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
• Receiving remuneration, or litigation pending, for their medical conditions

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology College of Osteopathic Medicine

Old Westbury, New York, 11568, United States

RECRUITING

Related Publications (5)

• Syx D, De Wandele I, Rombaut L, Malfait F. Hypermobility, the Ehlers-Danlos syndromes and chronic pain. Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):116-122. Epub 2017 Sep 28.

  PMID: 28967365 BACKGROUND

• Hakimi A, Bergoin C, Mucci P. What are the most important symptoms to assess in hypermobile Ehlers-Danlos syndrome? A questionnaire study based on the Delphi technique. Disabil Rehabil. 2022 Dec;44(26):8325-8331. doi: 10.1080/09638288.2021.2012839. Epub 2021 Dec 18.

  PMID: 34927503 BACKGROUND

• Cheng K, Martin LF, Slepian MJ, Patwardhan AM, Ibrahim MM. Mechanisms and Pathways of Pain Photobiomodulation: A Narrative Review. J Pain. 2021 Jul;22(7):763-777. doi: 10.1016/j.jpain.2021.02.005. Epub 2021 Feb 23.

  PMID: 33636371 BACKGROUND

• Martin LF, Patwardhan AM, Jain SV, Salloum MM, Freeman J, Khanna R, Gannala P, Goel V, Jones-MacFarland FN, Killgore WD, Porreca F, Ibrahim MM. Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial. Cephalalgia. 2021 Feb;41(2):135-147. doi: 10.1177/0333102420956711. Epub 2020 Sep 9.

  PMID: 32903062 BACKGROUND

• Martin L, Porreca F, Mata EI, Salloum M, Goel V, Gunnala P, Killgore WDS, Jain S, Jones-MacFarland FN, Khanna R, Patwardhan A, Ibrahim MM. Green Light Exposure Improves Pain and Quality of Life in Fibromyalgia Patients: A Preliminary One-Way Crossover Clinical Trial. Pain Med. 2021 Feb 4;22(1):118-130. doi: 10.1093/pm/pnaa329.

  PMID: 33155057 BACKGROUND

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Noto, DO

  NYITCOM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Noto, DO

CONTACT

516.686.4003; pnoto@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized clinical trial

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 30, 2022
• Study Start: November 21, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)