Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain
9. November 2017 aktualisiert von: John W. Reeves, MD
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.
Studienübersicht
Status
Suspendiert
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
150
Phase
- Frühphase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Louisiana
-
Shreveport, Louisiana, Vereinigte Staaten, 71106
- White Clover Wellness and Research Center
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Treatment Group
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 |
Nichtkohärente Lichtquelle, die 365 nm, 630 nm und 530 nm bei einer Ausgangsintensität von 0,1 mW direkt in einen vorhandenen intravaskulären 20-Gauge-1,0-Zoll-Katheter verabreichte
250 ml of 0.9% Sodium Chloride Solution
Andere Namen:
20-Gauge-1,0-Zoll-Katheter
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.
Zeitfenster: 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.
|
2 weeks
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Subject Satisfaction
Zeitfenster: 2 weeks
|
Self-reported overall treatment satisfaction based on perceived response from treatment
|
2 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: John W Reeves, MD, White Clover Wellness and Research Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
8. Februar 2017
Primärer Abschluss (Voraussichtlich)
31. Dezember 2018
Studienabschluss (Voraussichtlich)
31. Dezember 2018
Studienanmeldedaten
Zuerst eingereicht
6. August 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. August 2017
Zuerst gepostet (Tatsächlich)
11. August 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. November 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. November 2017
Zuletzt verifiziert
1. November 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- UVL_P001
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
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Nein
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Brai²nRekrutierungPersistent Spinal Pain Syndrome Typ 2 (PSPS-T2), untere Wirbelsäule | Spinale Rückenmarksempfindlichkeit gegenüber Neurostimulation | Neurophysiologische Empfindlichkeit gegenüber RückenmarksstimulationBelgien
Klinische Studien zur Behandlungsstation UVL1000
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Unity Health TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Canadian... und andere MitarbeiterUnbekannt
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Wearable Robotics srl.Azienda Ospedaliero, Universitaria Pisana; University Hospital, Geneva; Ecole...Beendet
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Centre Hospitalier Universitaire de NīmesZurückgezogen
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Universidade Estadual de LondrinaKU LeuvenUnbekanntLungenerkrankung, chronisch obstruktivBelgien, Brasilien
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UVLrx TherapeuticsAbgeschlossenLebensqualität | ErmüdungVereinigte Staaten
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Maastricht University Medical CenterAbgeschlossenGlioblastoma multiformeNiederlande, Belgien
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Damanhour UniversityAbgeschlossenOnkologische Patienten | EntspannungsprogrammÄgypten
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University of OklahomaUniversity at Buffalo; Save the ChildrenAbgeschlossen
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The Leeds Teaching Hospitals NHS TrustRekrutierungHerz-KreislaufVereinigtes Königreich
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Rigshospitalet, DenmarkRekrutierungHämatologischer Krebs | CRS – Zytokin-Freisetzungs-SyndromDänemark