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Acupuncture for Pain Control in the Emergency Department

3 december 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Korea, republiek van
    • Kyungsangnamdo
      • Yangsan, Kyungsangnamdo, Korea, republiek van, 626770
        • Pusan National University Yangsan Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: Standard ED management alone
Experimenteel: 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.
Procedure: Acupuncture plus standard ED management

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Immediate reduction in pain intensity
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Short-term reduction in pain intensity
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient acceptability of acupuncture treatment
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Korean Medicine Hospital of Pusan National University

Medewerkers

Korea Institute of Oriental Medicine

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2013

Primaire voltooiing (Werkelijk)

1 november 2015

Studie voltooiing (Werkelijk)

1 november 2015

Studieregistratiedata

Eerst ingediend

27 november 2013

Eerst ingediend dat voldeed aan de QC-criteria

11 december 2013

Eerst geplaatst (Schatting)

17 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

7 december 2015

Laatste update ingediend die voldeed aan QC-criteria

3 december 2015

Laatst geverifieerd

1 december 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ATPED

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