- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03293212
Characteristics and Medical Resource Utilization of Postoperative Patients
Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
Aperçu de l'étude
Statut
Les conditions
Description détaillée
A considerable number of patients suffer prolonged chronic pain that does not retract or diminish after surgery, and are thus unable to achieve the desired results in receiving surgical treatment. Postoperative pain is gradually being perceived as a social issue as opposed to a personal health condition. Meanwhile, although efforts to address chronic pain with integrative medicine are continued in answer to the lack of success of pain management through surgery, there is still a lack of supporting evidence.
The objective of this survey study is to assess the characteristics, usage of conventional and Korean medical services, and prognosis by period before and after surgery in postoperative patients visiting a Korean medicine hospital, and analyze the associations between the preference for conventional and Korean medicine treatment. This study therefore investigates the usage of conventional and Korean medical services in postoperative patients, and is expected to provide information that will potentially aid patient decision making.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Seoul, Corée, République de
- Jaseng Medical Foundation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients with chief complaint(s) of at least one or more of the following: low back pain (or radiating leg pain), neck pain (or radiating arm pain), knee pain, or shoulder pain
- Patients with a history of musculoskeletal surgery related to the chief complaint(s)
- Patients capable of effective communication with the researcher(s) and understanding the survey items
- Patients who have given written informed consent
Exclusion Criteria:
- Patients without a history of musculoskeletal surgery associated with the low back, neck, shoulder, or knee region(s)
- Patients whose current pain is mainly attributed to traffic accident injury
- Patients incapable of answering the researcher interviews and surveys
- Patients with other reasons rendering study participation inappropriate as judged by the researcher(s)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Numeric rating scale (NRS) of pain
Délai: Within 7 days after 1st visit
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11-point pain scale
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Within 7 days after 1st visit
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Five level version of EuroQol-5 Dimension (EQ-5D-5L)
Délai: Within 7 days after 1st visit
|
Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)
|
Within 7 days after 1st visit
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Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)
Délai: Within 7 days after 1st visit
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Oswestry Disability Index (ODI)
|
Within 7 days after 1st visit
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Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
Délai: Within 7 days after 1st visit
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Neck Disability Index (NDI)
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Within 7 days after 1st visit
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Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)
Délai: Within 7 days after 1st visit
|
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
|
Within 7 days after 1st visit
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Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)
Délai: Within 7 days after 1st visit
|
Shoulder Pain and Disability Index (SPADI)
|
Within 7 days after 1st visit
|
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Délai: Within 7 days after 1st visit
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Questionnaire assessing the effect of health problems on the ability to work and to perform regular activities
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Within 7 days after 1st visit
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Beck Depression Inventory-II (BDI-II)
Délai: Within 7 days after 1st visit
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The Korean version of the BDI-II has been validated and consists of 21 multiple choice items for diagnosis of depression.
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Within 7 days after 1st visit
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Medical service use
Délai: Within 7 days after 1st visit
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Type(s) of medical service use before and after surgery post-onset
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Within 7 days after 1st visit
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Medical costs
Délai: Within 7 days after 1st visit
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Medical costs from medical service use before and after surgery post-onset
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Within 7 days after 1st visit
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Satisfaction with and preference for conventional and Korean medicine
Délai: Within 7 days after 1st visit
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Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale
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Within 7 days after 1st visit
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: In-Hyuk Ha, KMD, M.Sc., Jaseng Medical Foundation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JS-CT-2017-03
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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