Ehlers-Danlos SyndromeLEEDSNCT05561270
Light Exposure on Pain in Hypermobile Ehlers-Danlos Syndrome
A study testing White LED light and Green LED light in people with Ehlers-Danlos Syndrome and Pain, Chronic, run by New York Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome, Pain, Chronic
- What is being tested?
- White LED light and Green LED light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Institute of Technology College of Osteopathic Medicine
Old Westbury, New York, 11568
Philip Noto, DO, pnoto@nyit.edu
Philip Noto, DO
About this study
Official 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.
Read the detailed description
Chronic pain is a major complaint among many individuals living with 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. A multidisciplinary approach, including pharmacologic and nonpharmacologic pain management, physical therapy, occupational therapy, and psychological treatment alongside prophylactic care and interventions has been recommended for these patients. The application of light for pain and injury has been studied for some time. More recently, specific colored light has shown promise in treating chronic pain. Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine. Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks. As no adverse events were reported, green light emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. 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.
Subjects will be enrolled for a total of 10 weeks, inclusive of either a 10-week control white light exposure period or a 10-week experimental green light exposure period. Central sensitization inventory will be used to determine the degree of central sensitization contributing to pain for each subject at baseline.
All subjects will be provided with a light source that will achieve light intensity of 4 and 100 lux measured at approximately 1 and 2 meters from point of exposure from a lux meter to determine the illuminance and luminous emittance of the LED strips. Subjects will be free to change the distance of the light source between 1 and 2 meters from their eyes to find the intensity that best suited them. The equipment will be provided during the initial clinic visit or mailed to the patients' homes and they will be instructed to use it in a dark room with no other source of light, except provided source, for a minimum of 1 hour every day, with the option to increase the exposure time to 2 hours daily for 10 weeks. The subjects will be asked to eliminate other sources of extraneous light (no use of televisions, computers, or smartphones; curtains drawn and existing room lights turned off) and will be encouraged to keep their eyes open, to blink at a normal rate, and not to stare directly at the light source. Subjects will be encouraged to engage in any activity while undergoing light exposure, such as reading or listening to music, and avoid falling asleep. Subjects will have the option to receive a daily text message/email reminder about light exposure and questionnaire completion. They will be provided with questionnaires to document the primary and secondary outcomes. Subjects will be allowed to continue their current medical therapy as recommended by their treating physicians. They will also be allowed to start any new medications as recommended by their treating physicians and instructed to document all medications used for their pain. Subjects will self-report the light exposure log, pain medication log, and pain severity data daily to minimize the chances of recall bias. Short-Form McGill Pain Questionnaire (SFMPQ) will be self-reported by subjects every 2 weeks. Short-Form 36 Health Survey (SF-36) data will be self-reported by subjects at their initial visit, 5-week visit, and 10-week visit. Athens Insomnia Scale (AIS) and Test My Brain (TMB) cognitive performance measures will be completed at baseline and week 10. The daily log and McGill Short-Form will be completed on paper. Other measures will be set up electronically for ease of patient completion and submission, but paper evaluations will be available as a back-up if there are technological difficulties. The TMB cognitive performance tests are performed on a computerized interactive interface and patients will be given access to the activities.
- Conditions
- Ehlers-Danlos Syndrome, Pain, Chronic
- Being tested
- White LED light, Green LED light
- Medical subject headings
- Ehlers-Danlos Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White LED lightDevice
Exposure to white LED light for 1-2 hours/day x 10 weeks
Green LED lightDevice
Exposure to green LED light for 1-2 hours/day x 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| White LED light | Sham comparator | Exposure to white LED light for 1-2 hours/day x 10 weeks Receives: Device: White LED light |
| Green LED light | Experimental | Exposure to green LED light for 1-2 hours/day x 10 weeks Receives: Device: Green LED light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 weeks
Secondary outcomes (7)
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.
Measured: 10 weeks
Changes in frequency of pain medication usage
Subjects will report frequency of any pain medications used through the duration of their participation
Measured: 10 weeks
Changes in dosage of pain medication used
Subjects will report dosages of any pain medications used through the duration of their participation
Measured: 10 weeks
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").
Measured: 10 weeks
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).
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start21 Nov 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Noto, DO, Principal investigator, NYITCOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561270
- Sponsor's protocol ID
- BHS-1755
- Acronym
- LEEDS
- Status last verified
- May 2024
- First submitted
- 20 Sep 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28967365Hakimi 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.
PubMed 34927503Cheng 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.
PubMed 33636371Martin 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.
PubMed 32903062Martin 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.
PubMed 33155057
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Light Exposure on Pain Severity and Quality of Life in Individuals With Hypermobile Ehlers-Danlos Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT05561270
- Acronym / sponsor ID
- LEEDS / BHS-1755
- Conditions
- Ehlers-Danlos Syndrome, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pain is a major complaint among many individuals living with 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. A multidisciplinary approach, including pharmacologic and nonpharmacologic pain management, physical therapy, occupational therapy, and psychological treatment alongside prophylactic care and interventions has been recommended for these patients. The application of light for pain and injury has been studied for some time. More recently, specific colored light has shown promise in treating chronic pain. Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine. Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks. As no adverse events were reported, green light emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. 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.
Subjects will be enrolled for a total of 10 weeks, inclusive of either a 10-week control white light exposure period or a 10-week experimental green light exposure period. Central sensitization inventory will be used to determine the degree of central sensitization contributing to pain for each subject at baseline.
All subjects will be provided with a light source that will achieve light intensity of 4 and 100 lux measured at approximately 1 and 2 meters from point of exposure from a lux meter to determine the illuminance and luminous emittance of the LED strips. Subjects will be free to change the distance of the light source between 1 and 2 meters from their eyes to find the intensity that best suited them. The equipment will be provided during the initial clinic visit or mailed to the patients' homes and they will be instructed to use it in a dark room with no other source of light, except provided source, for a minimum of 1 hour every day, with the option to increase the exposure time to 2 hours daily for 10 weeks. The subjects will be asked to eliminate other sources of extraneous light (no use of televisions, computers, or smartphones; curtains drawn and existing room lights turned off) and will be encouraged to keep their eyes open, to blink at a normal rate, and not to stare directly at the light source. Subjects will be encouraged to engage in any activity while undergoing light exposure, such as reading or listening to music, and avoid falling asleep. Subjects will have the option to receive a daily text message/email reminder about light exposure and questionnaire completion. They will be provided with questionnaires to document the primary and secondary outcomes. Subjects will be allowed to continue their current medical therapy as recommended by their treating physicians. They will also be allowed to start any new medications as recommended by their treating physicians and instructed to document all medications used for their pain. Subjects will self-report the light exposure log, pain medication log, and pain severity data daily to minimize the chances of recall bias. Short-Form McGill Pain Questionnaire (SFMPQ) will be self-reported by subjects every 2 weeks. Short-Form 36 Health Survey (SF-36) data will be self-reported by subjects at their initial visit, 5-week visit, and 10-week visit. Athens Insomnia Scale (AIS) and Test My Brain (TMB) cognitive performance measures will be completed at baseline and week 10. The daily log and McGill Short-Form will be completed on paper. Other measures will be set up electronically for ease of patient completion and submission, but paper evaluations will be available as a back-up if there are technological difficulties. The TMB cognitive performance tests are performed on a computerized interactive interface and patients will be given access to the activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-center, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| White LED light | Sham comparator | Device: White LED lightExposure to white LED light for 1-2 hours/day x 10 weeks |
| Green LED light | Experimental | Device: Green LED lightExposure to green LED light for 1-2 hours/day x 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White LED lightExposure to white LED light for 1-2 hours/day x 10 weeks | Device | White LED light |
| Green LED lightExposure to green LED light for 1-2 hours/day x 10 weeks | Device | Green LED light |
Primary outcome
Changes in pain intensity as measured by subject-reported numeric pain severity (NPS) rating
Time frame: 10 weeks
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)
7 secondary outcomes
Qualitative changes in pain as measured by Short-Form McGill Pain Questionnaire (SFMPQ)
Time frame: 10 weeks
Changes in frequency of pain medication usage
Time frame: 10 weeks
Changes in dosage of pain medication used
Time frame: 10 weeks
Health-related quality of life as measured by subject-reported Short-Form 36 Health Survey (SF-36)
Time frame: 10 weeks
Insomnia as measured by subject-reported Athens Insomnia Scale
Time frame: 10 weeks
Verbal memory as measured by "Test My Brain" (TMB) digital neuropsychiatry cognitive performance test
Time frame: 10 weeks
Sustained attention as measured by "Test My Brain" (TMB) digital neuropsychiatry cognitive performance test
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 28967365Syx 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.
- Background: PubMed 34927503Hakimi 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.
- Background: PubMed 33636371Cheng 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.
- Background: PubMed 32903062Martin 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.
- Background: PubMed 33155057Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Noto, DO principal investigator
NYITCOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White LED light and Green LED light in people with Ehlers-Danlos Syndrome and Pain, Chronic, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Noto, DO (516.686.4003, pnoto@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity as measured by subject-reported numeric pain severity (NPS) rating (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561270, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.