Phototherapy For Treatment Of Raynaud's Phenomenon

University of Minnesota (UMN)

Status: Withdrawn

Conditions: Raynaud Phenomenon; Raynaud Disease; Raynaud Syndrome

Treatments: Device: Blue Light Therapy; Device: Sham Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04898036

RHEUM-2021-29567

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Sham First, then Experimental

Experimental group

Description:

Participants in this group will receive the sham treatment first, then the experimental treatment.

Treatment:

Device: Sham Light Therapy

Device: Blue Light Therapy

Experimental First, then Sham

Experimental group

Description:

Participants in this group will receive the experimental treatment first, then the sham treatment.

Treatment:

Device: Sham Light Therapy

Device: Blue Light Therapy