Acupuncture for Pain Control in the Emergency Department

NCT ID: NCT02013908

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Neck Pain; Ankle Injuries; Headache Disorders, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard ED management alone

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Acupuncture plus standard ED management

Intervention Type: PROCEDURE

Interventions

Acupuncture plus standard ED management

Intervention Type: PROCEDURE

Standard ED management alone

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: collaborator

Korean Medicine Hospital of Pusan National University

OTHER

Sponsor Role: lead

Responsible Party

Gi Young Yang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gi Young Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Korean Medicine Hospital, Pusan National University

Ji Ho Ryu, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Kyungsangnamdo, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24928587 (View on PubMed)

Other Identifiers

ATPED

Identifier Type: -

Identifier Source: org_study_id