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Acupuncture for Pain Control in the Emergency Department

3. Dezember 2015 aktualisiert von: Gi Young Yang, Korean Medicine Hospital of Pusan National University

Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial

Acupuncture is widely used for managing acute and chronic pain conditions. In the context of an emergency department (ED), patients often present with non-emergent acute pain symptoms. This may result in a delayed triage process and inefficient emergent management. An integrative patient-care approach in emergency departments has been explored that may improve patient satisfaction and promote efficient use of healthcare resources for non-emergent patients in the ED. This implies there is a potential role for acupuncture in such contexts. The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headaches in an ED setting.

Hypotheses of this study are as follows:

  1. A single session of add-on acupuncture, with standard ED management, can reduce pain levels in non-emergent acute pain, compared to standard ED management alone.
  2. A single session of add-on acupuncture to standard ED management can reduce additional consumption of healthcare resources for management of non-emergent acute pain, compared to standard ED management alone.

This study aimed to include 40 participants, 20 in the acupuncture plus standard ED management group and 20 in the standard ED management alone group.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

17

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Korea, Republik von
    • Kyungsangnamdo
      • Yangsan, Kyungsangnamdo, Korea, Republik von, 626770
        • Pusan National University Yangsan Hospital

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

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Aged over 19 years with acute pain defined as pain occurring within 72 hours of ED presentation
  • Acute neck pain with no evidence of neurological abnormality
  • Acute headache which meets the classification criteria of a primary headache as described by the International Headache Society (code 1 to 4)
  • Acute ankle injury with no evidence of fracture or complete tear of ligaments

Exclusion Criteria:

  • Any suspected non-musculoskeletal cause (neoplasm or neurological complications) for neck or ankle pain
  • Any suspected secondary headaches classified by codes 5 to 12 in the International Classification of Headache Disorders, 2nd edition
  • Pain due to bone fracture or joint dislocation
  • Pain with fever (defined by a temperature above 37.5 °C)
  • Inappropriate at the ED physician's discretion
  • Pain level of less than 4 points of pain intensity on the Numerical Rating Scale (NRS) (range 0 to 10) at the completion of observations after the standard ED management
  • Pregnant women

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standard ED management alone
Radiographic and physical examinations to exclude fractures or other serious conditions will be performed for all patients before considering eligibility in the study. After completion of the examination, patients who have pain of at least a level 4, as measured by the Wong-Baker scale (ranges 0 to 10), will receive intravenous or intramuscular injections of non-steroidal anti-inflammatory drugs (NSAIDs) for immediate pain control. All patients will be observed 30 minutes after the administration of the NSAIDs. In patients with primary headaches who respond poorly to the initial NSAID injection, an intravenous injection of opioid analgesics will be provided. After these initial standard ED management interventions, patients who are still suffering from acute pain will be asked to participate in the trial. During the study, rescue medication for immediate pain control will be allowed for patients allocated to both groups.
Verfahren: Standard ED management alone
Experimental: Acupuncture plus standard ED management
The patients in this group will receive a single session of individualized acupuncture treatment delivered by a certified Korean Medicine Doctor (KMD) specialized (or in-training) in acupuncture and moxibustion medicine and with at least 3 years of clinical experience. The acupuncture formulas will be composed based on the individual patient's symptoms and at the KMD's discretion. Acupuncture treatments will be provided in line with standard ED management, the same as in the control group.
Verfahren: Acupuncture plus standard ED management

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Immediate reduction in pain intensity
Zeitfenster: at ED discharge (within 3 hours from ED admission)
Participant-perceived reduction of pain intensity will be measured by the pain Numerical Rating Scale (NRS) (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)
at ED discharge (within 3 hours from ED admission)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Short-term reduction in pain intensity
Zeitfenster: 72 hours after the ED discharge
Participant-perceived reduction of pain intensity will be measured by the the pain NRS (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)
72 hours after the ED discharge
Short-term disability due to neck pain (only for patients with neck pain)
Zeitfenster: 72 hours after the ED discharge
Participant-perceived reduction of disability due to neck pain will be measured by a 10-item questionnaire. Changes from baseline on the Neck Disability Index (NDI) will be used.
72 hours after the ED discharge
Immediate and short-term patient global assessment for treatment outcomes
Zeitfenster: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Patients' global assessments for overall treatment outcomes will be measured by a single item with a 5-point Likert scale question (much improved, somewhat improved, the same as baseline, somewhat worsened, much worsened)
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Use of rescue medication in the ED
Zeitfenster: at ED discharge (within 3 hours from ED admission)
Use of additional rescue medication for relieving pain will be measured by electronic medical charts
at ED discharge (within 3 hours from ED admission)
Use of additional medication or healthcare resources
Zeitfenster: 72 hours after the ED discharge
Use of additional medication or healthcare resources (such as hospital admissions and outpatient clinic visits) will be measured by patients' self-reports via telephone interviews.
72 hours after the ED discharge
Length of stay in the ED
Zeitfenster: at ED discharge (within 3 hours from ED admission)
Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.
at ED discharge (within 3 hours from ED admission)
Proportion of treatment responder
Zeitfenster: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Proportion of treatment responder is defined as patients who have experienced at least a 50% reduction in pain intensity from baseline values; these values will be calculated using the pain intensity VAS scores.
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Adverse events
Zeitfenster: at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
All expected or unexpected adverse events in both groups will be measured during the allocated intervention process and during the entire follow-up period. Types and frequency of occurrences of adverse events will be measured.
at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient acceptability of acupuncture treatment
Zeitfenster: 72 hours after the ED discharge
Participant-perceived acceptability of acupuncture treatment will be measured by a single item with a 5-point Likert scale question (acupuncture was very helpful, somewhat helpful, don't know, somewhat not helpful, very not helpful).
72 hours after the ED discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Korean Medicine Hospital of Pusan National University

Mitarbeiter

Korea Institute of Oriental Medicine

Ermittler

  • Hauptermittler: Gi Young Yang, PhD, Korean Medicine Hospital, Pusan National University
  • Hauptermittler: Ji Ho Ryu, PhD, Pusan National University Yangsan Hospital

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.

Allgemeine Veröffentlichungen

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

1. Dezember 2013

Primärer Abschluss (Tatsächlich)

1. November 2015

Studienabschluss (Tatsächlich)

1. November 2015

Studienanmeldedaten

Zuerst eingereicht

27. November 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Dezember 2013

Zuerst gepostet (Schätzen)

17. Dezember 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

7. Dezember 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Dezember 2015

Zuletzt verifiziert

1. Dezember 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ATPED

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