An interventional study of Acupuncture plus standard ED management and Standard ED management alone in Neck Pain, Ankle Injuries and Headache Disorders, Primary, sponsored by Korean Medicine Hospital of Pusan National University. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-12-07.
Sponsored by Korean Medicine Hospital of Pusan National University · Not applicable, Interventional, and Treatment
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:
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.
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's enrollment of 17 is below the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Korean Medicine Hospital of Pusan National University is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Immediate reduction in pain intensity
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)
Time frame: at ED discharge (within 3 hours from ED admission)
Short-term reduction in pain intensity
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)
Time frame: 72 hours after the ED discharge
Short-term disability due to neck pain (only for patients with neck pain)
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.
Time frame: 72 hours after the ED discharge
Immediate and short-term patient global assessment for treatment outcomes
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)
Time frame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Use of rescue medication in the ED
Use of additional rescue medication for relieving pain will be measured by electronic medical charts
Time frame: at ED discharge (within 3 hours from ED admission)
Use of additional medication or healthcare resources
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.
Time frame: 72 hours after the ED discharge
Length of stay in the ED
Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.
Time frame: at ED discharge (within 3 hours from ED admission)
Proportion of treatment responder
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.
Time frame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Adverse events
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.
Time frame: at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
Patient acceptability of acupuncture treatment
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).
Time frame: 72 hours after the ED discharge
This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Korean Medicine Hospital of Pusan National University