Clinical trial NCT03246282: Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain
Official title: A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Pain Reduction Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Pain
Lead sponsor: White Clover Research Foundation
Sponsor class: OTHER
Collaborators: name: White Clover Research Foundation
name: White Clover Wellness and Research Center
First posted: 2017-08-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
measure: Subject Satisfaction
timeFrame: 2 weeks
Locations:
city: Shreveport
country: United States
facility: White Clover Wellness and Research Center
state: Louisiana
Study officials:
affiliation: White Clover Wellness and Research Center
name: John W Reeves, MD
role: PRINCIPAL_INVESTIGATOR
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