Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain

• Status: Suspended
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: John W. Reeves, MD
• Collaborators: White Clover Research Foundation; White Clover Wellness and Research Center
• Treatments: Pharmaceutical Solutions

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