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Acupuncture for Pain Control in the Emergency Department

Primary Purpose

Neck Pain, Ankle Injuries, Headache Disorders, Primary

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture plus standard ED management
Standard ED management alone
Sponsored by
Korean Medicine Hospital of Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring acupuncture, emergency department, acute pain, ankle sprain, neck pain, primary headache

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard ED management alone

Acupuncture plus standard ED management

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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)
Use of rescue medication in the ED
Use of additional rescue medication for relieving pain will be measured by electronic medical charts
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.
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.
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.
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.

Full Information

First Posted
November 27, 2013
Last Updated
December 3, 2015
Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02013908
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate (17 patients;43% enrollment for 2 years).
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Ankle Injuries, Headache Disorders, Primary
Keywords
acupuncture, emergency department, acute pain, ankle sprain, neck pain, primary headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard ED management alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acupuncture plus standard ED management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture plus standard ED management
Intervention Type
Procedure
Intervention Name(s)
Standard ED management alone
Primary Outcome Measure Information:
Title
Immediate reduction in pain intensity
Description
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)
Time Frame
at ED discharge (within 3 hours from ED admission)
Secondary Outcome Measure Information:
Title
Short-term reduction in pain intensity
Description
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)
Time Frame
72 hours after the ED discharge
Title
Short-term disability due to neck pain (only for patients with neck pain)
Description
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.
Time Frame
72 hours after the ED discharge
Title
Immediate and short-term patient global assessment for treatment outcomes
Description
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)
Time Frame
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Title
Use of rescue medication in the ED
Description
Use of additional rescue medication for relieving pain will be measured by electronic medical charts
Time Frame
at ED discharge (within 3 hours from ED admission)
Title
Use of additional medication or healthcare resources
Description
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.
Time Frame
72 hours after the ED discharge
Title
Length of stay in the ED
Description
Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.
Time Frame
at ED discharge (within 3 hours from ED admission)
Title
Proportion of treatment responder
Description
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.
Time Frame
at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
Title
Adverse events
Description
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.
Time Frame
at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
Other Pre-specified Outcome Measures:
Title
Patient acceptability of acupuncture treatment
Description
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).
Time Frame
72 hours after the ED discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gi Young Yang, PhD
Organizational Affiliation
Korean Medicine Hospital, Pusan National University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ji Ho Ryu, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Kyungsangnamdo
ZIP/Postal Code
626770
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24928587
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.
Results Reference
derived

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Acupuncture for Pain Control in the Emergency Department

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