Pain, Chronic Clinical Trial
— LEEDSOfficial title:
Investigation of Light Exposure on Pain Severity and Quality of Life in Individuals With Hypermobile Ehlers-Danlos Syndrome: A Pilot Study
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | November 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | New York Institute of Technology College of Osteopathic Medicine | Old Westbury | New York |
Lead Sponsor | Collaborator |
---|---|
New York Institute of Technology |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Qualitative changes in pain as measured by Short-Form McGill Pain Questionnaire (SFMPQ) | Subjects will describe pain per Short-Form McGill Pain Questionnaire (SFMPQ) every 2 weeks through the duration of their participation. In this questionnaire, subjects will rate their pain on scales from 0 (no pain) to 3 (severe pain). Higher scores indicate worse outcomes. | 10 weeks | |
Secondary | Changes in frequency of pain medication usage | Subjects will report frequency of any pain medications used through the duration of their participation | 10 weeks | |
Secondary | Changes in dosage of pain medication used | Subjects will report dosages of any pain medications used through the duration of their participation | 10 weeks | |
Secondary | Health-related quality of life as measured by subject-reported Short-Form 36 Health Survey (SF-36) | Subjects will complete Short-Form 36 Health Survey (SF-36) at baseline, week 5, and week 10. This survey asks subjects to qualitatively rate their health-related limitations of activities of daily living on Likert scales (e.g. ranging from "no limitation" to "severe limitation"). | 10 weeks | |
Secondary | Insomnia as measured by subject-reported Athens Insomnia Scale | Subjects will complete Athens Insomnia Scale at baseline and week 10. Subjects will rate aspects of their sleep quality on this scale from 0 (no problem) to 3 (severe problem). | 10 weeks | |
Secondary | Verbal memory as measured by "Test My Brain" (TMB) digital neuropsychiatry cognitive performance test | Subjects will complete "Test My Brain" (TMB) digital neuropsychiatry cognitive performance test assessing verbal memory at baseline and week 10. This computerized test calculates the subject's performance in learning and recognizing sets of word pairs. Performance is digitally analyzed, quantified and compared against normative data by age, gender and education level. Higher scores are associated with improved outcomes. | 10 weeks | |
Secondary | Sustained attention as measured by "Test My Brain" (TMB) digital neuropsychiatry cognitive performance test | Subjects will complete "Test My Brain" (TMB) digital neuropsychiatry cognitive performance test assessing sustained attention at baseline and week 10. This computerized test calculates the subject's performance in recognizing and responding to sets of rapidly transitioning images. Performance is digitally analyzed, quantified and compared against normative data by age, gender and education level. Higher scores are associated with improved outcomes. | 10 weeks |
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