Acupuncture for Pain Control in the Emergency Department

NCT02013908 | Terminated DMC

• 1 other identifier: ATPED
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Neck Pain; Ankle Injuries; Headache Disorders, Primary

Keywords

acupuncture; emergency department; acute pain; ankle sprain; neck pain; primary headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

Other Outcomes (1)

• Patient acceptability of acupuncture treatment

  72 hours after the ED discharge

Study Arms (2)

Standard ED management alone

ACTIVE COMPARATOR

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

Acupuncture plus standard ED management

EXPERIMENTAL

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

Interventions

Acupuncture plus standard ED management PROCEDURE

Acupuncture plus standard ED management

Standard ED management alone PROCEDURE

Standard ED management alone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Medicine Hospital of Pusan National University: lead
• Korea Institute of Oriental Medicine: collaborator

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Kyungsangnamdo, 626770, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24928587 DERIVED

MeSH Terms

Conditions

Neck Pain; Ankle Injuries; Headache Disorders, Primary; Emergencies; Acute Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leg Injuries; Wounds and Injuries; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Gi Young Yang, PhD

  Korean Medicine Hospital, Pusan National University

  PRINCIPAL INVESTIGATOR

• Ji Ho Ryu, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 17, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

KR (1)