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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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.
To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.
University of Minnesota
Minneapolis, Minnesota, United States
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.
Time frame: 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.
Time frame: 4 hours
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.
Time frame: 4 hours
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