Clinical trial NCT02013908: Acupuncture for Pain Control in the Emergency Department
Official title: Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neck Pain
Ankle Injuries
Headache Disorders, Primary
Keywords: acupuncture
emergency department
acute pain
ankle sprain
neck pain
primary headache
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2013-12-17
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immediate reduction in pain intensity
timeFrame: at ED discharge (within 3 hours from ED admission)
Secondary outcomes:
measure: Short-term reduction in pain intensity
timeFrame: 72 hours after the ED discharge
measure: Short-term disability due to neck pain (only for patients with neck pain)
timeFrame: 72 hours after the ED discharge
measure: Immediate and short-term patient global assessment for treatment outcomes
timeFrame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
measure: Use of rescue medication in the ED
timeFrame: at ED discharge (within 3 hours from ED admission)
measure: Use of additional medication or healthcare resources
timeFrame: 72 hours after the ED discharge
measure: Length of stay in the ED
timeFrame: at ED discharge (within 3 hours from ED admission)
measure: Proportion of treatment responder
timeFrame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
measure: Adverse events
timeFrame: at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
Other outcomes:
measure: Patient acceptability of acupuncture treatment
timeFrame: 72 hours after the ED discharge
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyungsangnamdo
Study officials:
affiliation: Korean Medicine Hospital, Pusan National University
name: Gi Young Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Yangsan Hospital
name: Ji Ho Ryu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.