Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain
9 novembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Suspendu
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
150
Phase
- Première phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Louisiana
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Shreveport, Louisiana, États-Unis, 71106
- White Clover Wellness and Research Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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 |
Source de lumière non cohérente administrée à 365 nm, 630 nm et 530 nm à une intensité de sortie de 0,1 mW directement dans un cathéter intravasculaire existant de calibre 20 de 1,0"
250 ml of 0.9% Sodium Chloride Solution
Autres noms:
Cathéter de 1,0" de calibre 20
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.
Délai: 2 weeks
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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.
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2 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subject Satisfaction
Délai: 2 weeks
|
Self-reported overall treatment satisfaction based on perceived response from treatment
|
2 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: John W Reeves, MD, White Clover Wellness and Research Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 février 2017
Achèvement primaire (Anticipé)
31 décembre 2018
Achèvement de l'étude (Anticipé)
31 décembre 2018
Dates d'inscription aux études
Première soumission
6 août 2017
Première soumission répondant aux critères de contrôle qualité
9 août 2017
Première publication (Réel)
11 août 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 novembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 novembre 2017
Dernière vérification
1 novembre 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- UVL_P001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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Zurich Center for Integrative Human PhysiologyInconnue
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Bogumiła PniakComplétéAccident vasculaire cérébral | Réhabilitation | BiofeedbackPologne
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Hospital Clinic of BarcelonaInconnue
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Universidade Estadual de LondrinaKU LeuvenInconnueMaladie pulmonaire obstructive chroniqueBelgique, Brésil
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University of RzeszowComplétéRéhabilitation | Maladies neurologiques | BiofeedbackPologne
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Maastricht University Medical CenterComplété