- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03293212
Characteristics and Medical Resource Utilization of Postoperative Patients
Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Seoul, Korea, Republik von
- Jaseng Medical Foundation
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Numeric rating scale (NRS) of pain
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Five level version of EuroQol-5 Dimension (EQ-5D-5L)
Zeitfenster: Within 7 days after 1st visit
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Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)
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Within 7 days after 1st visit
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Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)
Zeitfenster: Within 7 days after 1st visit
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Oswestry Disability Index (ODI)
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Within 7 days after 1st visit
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Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
Zeitfenster: 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)
Zeitfenster: Within 7 days after 1st visit
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Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
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Within 7 days after 1st visit
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Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)
Zeitfenster: Within 7 days after 1st visit
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Shoulder Pain and Disability Index (SPADI)
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Within 7 days after 1st visit
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Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: In-Hyuk Ha, KMD, M.Sc., Jaseng Medical Foundation
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JS-CT-2017-03
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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