Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain

NCT03246282 | Suspended Early Phase 1 DMC FDA Device

• 1 other identifier: UVL_P001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Subject Satisfaction

  2 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Polychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by light emitting diode(s). A small adapter attaches directly to a standard 20-guage catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the proximal end of the catheter. Polychromatic light is emitted to illuminate the catheter near the site of catheter entrance. Concurrently, normal saline flows through the optic adapter, into and through the 20-gauge catheter. Device: UVL1000 Treatment Station Drug: Normal Saline 0.9% Infusion Solution Bag Device: Peripheral Catheterization

Device: UVL1000 Treatment Station; Drug: Normal Saline 0.9% Infusion Solution Bag; Device: Peripheral Catheterization

Interventions

UVL1000 Treatment Station DEVICE

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

Treatment Group

Normal Saline 0.9% Infusion Solution Bag DRUG

250 ml of 0.9% Sodium Chloride Solution

Also known as: Normal Saline

Treatment Group

Peripheral Catheterization DEVICE

20-gauge 1.0" catheter

Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John W. Reeves, MD: lead
• White Clover Research Foundation: collaborator
• White Clover Wellness and Research Center: collaborator

Study Sites (1)

White Clover Wellness and Research Center

Shreveport, Louisiana, 71106, United States

Location

Related Publications (67)

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MeSH Terms

Conditions

Pain

Interventions

Saline Solution; Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• John W Reeves, MD

  White Clover Wellness and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: John W. Reeves, MD

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 11, 2017
• Study Start: February 8, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)