Low recruitment rate (17 patients;43% enrollment for 2 years).
Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial
Sponsor study identifier
interventional
17
1 country
1
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2013
Actual (reported)December 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 17, 2013
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)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)
Short-term reduction in pain intensity
72 hours after the ED discharge
Short-term disability due to neck pain (only for patients with neck pain)
72 hours after the ED discharge
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pusan National University Yangsan Hospital
Yangsan, Kyungsangnamdo, 626770, South Korea
Kim KH, Ryu JH, Park MR, Kim YI, Min MK, Park YM, Kim YR, Noh SH, Kang MJ, Kim YJ, Kim JK, Lee BR, Choi JY, Yang GY. Acupuncture as analgesia for non-emergent acute non-specific neck pain, ankle sprain and primary headache in an emergency department setting: a protocol for a parallel group, randomised, controlled pilot trial. BMJ Open. 2014 Jun 12;4(6):e004994. doi: 10.1136/bmjopen-2014-004994.
Gi Young Yang, PhD
Korean Medicine Hospital, Pusan National University
Ji Ho Ryu, PhD
Pusan National University Yangsan Hospital
17 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2013
First Posted
December 17, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Immediate and short-term patient global assessment for treatment outcomes
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Use of rescue medication in the ED
at ED discharge (within 3 hours from ED admission)
Use of additional medication or healthcare resources
72 hours after the ED discharge
Patient acceptability of acupuncture treatment
72 hours after the ED discharge
Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
December 7, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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