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Lack of Funding
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| Name | Class |
|---|---|
| White Clover Research Foundation | OTHER |
| White Clover Wellness and Research Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Self-reported overall treatment satisfaction based on perceived response from treatment | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Reeves, MD | White Clover Wellness and Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White Clover Wellness and Research Center | Shreveport | Louisiana | 71106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15573690 | Background | Giuliani A, Fernandez M, Farinelli M, Baratto L, Capra R, Rovetta G, Monteforte P, Giardino L, Calza L. Very low level laser therapy attenuates edema and pain in experimental models. Int J Tissue React. 2004;26(1-2):29-37. | |
| 25800533 | Background | Xu Y, Lin Y, Gao S. Study on the selection of laser wavelengths in the intravascular low-level laser irradiation therapy. Lasers Med Sci. 2015 May;30(4):1373-6. doi: 10.1007/s10103-015-1732-7. Epub 2015 Mar 24. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline 0.9% Infusion Solution Bag | Drug | 250 ml of 0.9% Sodium Chloride Solution |
|
|
| Peripheral Catheterization | Device | 20-gauge 1.0" catheter |
|
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| D002404 |
| Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |