Clinical Trial: Acupuncture for Pain Control in the Emergency Department

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Korean Medicine Hospital of Pusan National University

Current Primary Outcome: Immediate reduction in pain intensity [ Time Frame: 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)


Original Primary Outcome: Immediate reduction in pain intensity [ Time Frame: at ED discharge (within 3 hours from ED admission) ]

Participant-perceived reduction of pain intensity will be measured by the pain Visual Analogue Scale (VAS)


Current Secondary Outcome:

  • Short-term reduction in pain intensity [ Time Frame: 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)
  • Short-term disability due to neck pain (only for patients with neck pain) [ Time Frame: 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.
  • Immediate and short-term patient global assessment for treatment outcomes [ Time Frame: 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)
  • Use of rescue medication in the ED [ Time Frame: at ED discharge (within 3 hours from ED admission) ]
    Use of additional rescue medication for relieving pain will be measured by electronic medical charts
  • Use of additional medication or healthcare resources [ Time Frame: 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.
  • Length of stay in the ED [ Time Frame: 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.
  • Proportion of treatment responder [ Time Frame: 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.
  • Adverse events [ Time Frame: 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.


Original Secondary Outcome:

  • Short-term reduction in pain intensity [ Time Frame: 72 hours after the ED discharge ]
    Participant-perceived reduction of pain intensity will be measured by the pain VAS.
  • Short-term disability due to neck pain (only for patients with neck pain) [ Time Frame: 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.
  • Immediate and short-term patient global assessment for treatment outcomes [ Time Frame: 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)
  • Use of rescue medication in the ED [ Time Frame: at ED discharge (within 3 hours from ED admission) ]
    Use of additional rescue medication for relieving pain will be measured by electronic medical charts
  • Use of additional medication or healthcare resources [ Time Frame: 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.
  • Length of stay in the ED [ Time Frame: 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.
  • Proportion of treatment responder [ Time Frame: 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.
  • Adverse events [ Time Frame: 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.


Information By: Korean Medicine Hospital of Pusan National University

Dates:
Date Received: November 27, 2013
Date Started: December 2013
Date Completion:
Last Updated: December 3, 2015
Last Verified: December 2015