Phototherapy For Treatment Of Raynaud's Phenomenon

Study Overview
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Brief Summary
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To determine if blue light therapy can improve the symptoms of Raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.

Detailed Description
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The purpose of this study is to test the efficacy of blue light phototherapy for the treatment of Raynaud's phenomenon (RP) in human participants. The specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that RP participants experience. This will be measured through the use of a visual analog scale (VAS) of both pain and numbness. This study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. Together, the visual analog scale (VAS) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced RP symptoms due to vasodilation of blood vessels.

Official Title
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Phototherapy For Treatment Of Raynaud's Phenomenon

Conditions
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Raynaud Disease, Raynaud Phenomenon, Raynaud Syndrome

Intervention / Treatment
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* Device: Blue Light Therapy
* Device: Sham Light Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome Exclusion Criteria: Those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them. Inability of the subject to place their hands into the PTD portal because of physical size or discomfort. Inability of the subject to wear protective eyewear. Anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures. Females who are pregnant. Adults unable to consent for any reason not explicitly stated herein.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sham First, then Experimental<br>Participants in this group will receive the sham treatment first, then the experimental treatment. | Device: Blue Light Therapy<br>* This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.<br>Device: Sham Light Therapy<br>* To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.<br>|
| Experimental: Experimental First, then Sham<br>Participants in this group will receive the experimental treatment first, then the sham treatment. | Device: Blue Light Therapy<br>* This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.<br>Device: Sham Light Therapy<br>* To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) of Pain | Participants will be asked to rate their pain upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters. | 4 hours | 
| Change in Visual Analog Scale (VAS) of Numbness | Participants will be asked to rate their numbness upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Temperature | Skin temperature of at least one finger will be measured and logged using a thermometer at multiple points during study visit. Outcome is reported in units of degrees Celsius. | 4 hours |