Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain

Study Overview
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Brief Summary
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This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.

Detailed Description
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This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of Polychromatic Light Emitting Diode System (PLEDS) for Peripheral Intravenous (PIV) catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies. PIV therapy has been used for decades as an effective therapy to maintain proper hydration and electrolyte levels. Additionally, PIV therapy can be infused with various agents, including supplements and pharmacological agents. Low-energy light therapy has been established as an alternative treatment for a myriad of medical conditions including reduction of pain. The concurrent administration of low-light therapy and PIV therapy may serve as a viable therapy for the treatment of pain associated with various medical conditions. Accordingly, this study is designed to assess the feasibility of low light therapy via PLEDS integrated into a standard PIV catheter for the purposes of reduction of pain.

Official Title
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A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Pain Reduction Study

Conditions
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Pain

Intervention / Treatment
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* Device: UVL1000 Treatment Station
* Drug: Normal Saline 0.9% Infusion Solution Bag
* Device: Peripheral Catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed informed consent form (see Informed Consent Forms) Ages 18-70 Non-Pregnant Female Participants Self-reported perceived pain score via Brief Pain Inventory - Short Form score of 2 or more. No breastfeeding for 1 week prior to enrollment Birth control measures to be used throughout the duration of the study for women of child bearing potential Powerful antioxidants (e.g. oral antioxidants, Vitamin C and E, glutathione or Myer's cocktail IV infusion therapy) will not be used on treatment days Exclusion Criteria: Active infection along potential intravenous catheter sites Use of anti-inflammatory medications on day of treatment and no more than 400mg per day for over 30 days Suffering from blood clotting disorders (hypercoagulable condition, thrombocytosis, etc.) Participated in a clinical study in the last 14 days Breastfeeding Currently taking photosensitizing agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Polychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by light emitting diode(s). A small adapter attaches directly to a standard 20-guage catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the proximal end of the catheter. Polychromatic light is emitted to illuminate the catheter near the site of catheter entrance. Concurrently, normal saline flows through the optic adapter, into and through the 20-gauge catheter. Device: UVL1000 Treatment Station Drug: Normal Saline 0.9% Infusion Solution Bag Device: Peripheral Catheterization | Device: UVL1000 Treatment Station<br>* Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0 catheter<br>Drug: Normal Saline 0.9% Infusion Solution Bag<br>* 250 ml of 0.9% Sodium Chloride Solution<br>* Other names: Normal Saline;Device: Peripheral Catheterization<br>* 20-gauge 1.0 catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score. | To evaluate the feasibility of PLEDS for PIV catheter light delivery for the purposes of pain reduction, through assessing the change between baseline average pain (via Brief Pain Inventory - Short Form) and final average VAS score (via the Per Treatment VAS Score Form) following treatment administration. | 2 weeks |