Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03246282
• Other study ID #: UVL_P001
• Status: Suspended
• Phase: Early Phase 1
• First received: August 6, 2017
• Last updated: November 9, 2017
• Start date: February 8, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: White Clover Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• UVL1000 Treatment Station
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

Drug:
• Normal Saline 0.9% Infusion Solution Bag
250 ml of 0.9% Sodium Chloride Solution

Device:
• Peripheral Catheterization
20-gauge 1.0" catheter

Locations

Country	Name	City	State
United States	White Clover Wellness and Research Center	Shreveport	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
John W. Reeves, MD	White Clover Research Foundation, White Clover Wellness and Research Center

Country where clinical trial is conducted

United States, 

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* Note: There are 67 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject Satisfaction	Self-reported overall treatment satisfaction based on perceived response from treatment	2 weeks
Primary	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