Acupuncture for Pain Control in the Emergency Department

Neck Pain Clinical Trial

Official title:

Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02013908
• Other study ID #: ATPED
• Status: Terminated
• Phase: N/A
• First received: November 27, 2013
• Last updated: December 3, 2015
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Emergencies
• Headache
• Headache Disorders
• Headache Disorders, Primary
• Neck Pain

Intervention

Procedure:
• Acupuncture plus standard ED management

• Standard ED management alone

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyungsangnamdo

Sponsors (2)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University	Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient acceptability of acupuncture treatment	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).	72 hours after the ED discharge	No
Primary	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)	No
Secondary	Short-term reduction in pain intensity	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)	72 hours after the ED discharge	No
Secondary	Short-term disability due to neck pain (only for patients with neck pain)	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.	72 hours after the ED discharge	No
Secondary	Immediate and short-term patient global assessment for treatment outcomes	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)	at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge	No
Secondary	Use of rescue medication in the ED	Use of additional rescue medication for relieving pain will be measured by electronic medical charts	at ED discharge (within 3 hours from ED admission)	No
Secondary	Use of additional medication or healthcare resources	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.	72 hours after the ED discharge	No
Secondary	Length of stay in the ED	Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.	at ED discharge (within 3 hours from ED admission)	No
Secondary	Proportion of treatment responder	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.	at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge	No
Secondary	Adverse events	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.	at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge	Yes