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Acupuncture for Pain Control in the Emergency Department

3 dicembre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

17

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea, Repubblica di
    • Kyungsangnamdo
      • Yangsan, Kyungsangnamdo, Corea, Repubblica di, 626770
        • Pusan National University Yangsan Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: Standard ED management alone
Sperimentale: 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.
Procedura: Acupuncture plus standard ED management

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Immediate reduction in pain intensity
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Short-term reduction in pain intensity
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient acceptability of acupuncture treatment
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Korean Medicine Hospital of Pusan National University

Collaboratori

Korea Institute of Oriental Medicine

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2013

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

1 novembre 2015

Date di iscrizione allo studio

Primo inviato

27 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

11 dicembre 2013

Primo Inserito (Stima)

17 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 dicembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 dicembre 2015

Ultimo verificato

1 dicembre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ATPED

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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