Acupuncture for Pain Control in the Emergency Department

Study Overview
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Brief Summary
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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: 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. 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.

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

Conditions
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Neck Pain, Ankle Injuries, Headache Disorders, Primary

Intervention / Treatment
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* Procedure: Acupuncture plus standard ED management
* Procedure: Standard ED management alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard ED management alone<br>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<br> <br> |
| Experimental: Acupuncture plus standard ED management<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | at ED discharge (within 3 hours from ED admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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) | 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 | 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. | 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. | 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. | 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. | at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, emergency department, acute pain, ankle sprain, neck pain, primary headache