Acupuncture for Pain Control in the Emergency Department
|ClinicalTrials.gov Identifier: NCT02013908|
Recruitment Status : Terminated (Low recruitment rate (17 patients;43% enrollment for 2 years).)
First Posted : December 17, 2013
Last Update Posted : December 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Ankle Injuries Headache Disorders, Primary||Procedure: Acupuncture plus standard ED management Procedure: Standard ED management alone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: 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|
Experimental: 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|
- 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)
- 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.
- Patient acceptability of acupuncture treatment [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013908
|Korea, Republic of|
|Pusan National University Yangsan Hospital|
|Yangsan, Kyungsangnamdo, Korea, Republic of, 626770|
|Principal Investigator:||Gi Young Yang, PhD||Korean Medicine Hospital, Pusan National University|
|Principal Investigator:||Ji Ho Ryu, PhD||Pusan National University Yangsan Hospital|