Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain
| Status: | Suspended |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/16/2017 |
| Start Date: | February 8, 2017 |
| End Date: | December 31, 2018 |
A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Pain Reduction Study
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.
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.
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.
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.
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
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