Phototherapy For Treatment Of Raynaud's Phenomenon

Not Applicable

Withdrawn

• Conditions: Raynaud Syndrome; Raynaud Disease; Raynaud Phenomenon
• Interventions: Device: Blue Light Therapy; Device: Sham Light Therapy

• Registration Number: NCT04898036
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Study Start: 2022-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental First, then Sham	Sham Light Therapy	Participants in this group will receive the experimental treatment first, then the sham treatment.
Sham First, then Experimental	Blue Light Therapy	Participants in this group will receive the sham treatment first, then the experimental treatment.
Sham First, then Experimental	Sham Light Therapy	Participants in this group will receive the sham treatment first, then the experimental treatment.
Experimental First, then Sham	Blue Light Therapy	Participants in this group will receive the experimental treatment first, then the sham treatment.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) of Numbness	4 hours	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.
Change in Visual Analog Scale (VAS) of Pain	4 hours	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.

Secondary Outcome Measures

Name	Time	Method
Skin Temperature	4 hours	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States