Pain
Conditions
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.
Interventions
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
250 ml of 0.9% Sodium Chloride Solution
20-gauge 1.0 catheter
Sponsors
White Clover Research Foundation
White Clover Wellness and Research Center
John W. Reeves, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score. | 2 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 2 weeks | Self-reported overall treatment satisfaction based on perceived response from treatment |
Countries
United States
Outcome results
None listed