Trial record 6 of 611 for:    "Headache Disorders"

Acupuncture for Pain Control in the Emergency Department

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Korean Medicine Hospital of Pusan National University
Sponsor:
Collaborator:
Korea Institute of Oriental Medicine
Information provided by (Responsible Party):
Gi Young Yang, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier:
NCT02013908
First received: November 27, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Neck Pain
Ankle Injuries
Headache Disorders, Primary
Procedure: Acupuncture plus standard ED management
Procedure: Standard ED management alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial

Resource links provided by NLM:


Further study details as provided by Korean Medicine Hospital of Pusan National University:

Primary Outcome Measures:
  • Immediate reduction in pain intensity [ Time Frame: at ED discharge (within 3 hours from ED admission) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 72 hours after the ED discharge ] [ Designated as safety issue: No ]
    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) [ Time Frame: 72 hours after the ED discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: at ED discharge (within 3 hours from ED admission) ] [ Designated as safety issue: No ]
    Use of additional rescue medication for relieving pain will be measured by electronic medical charts

  • Use of additional medication or healthcare resources [ Time Frame: 72 hours after the ED discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: at ED discharge (within 3 hours from ED admission) ] [ Designated as safety issue: No ]
    Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.

  • Proportion of treatment responder [ Time Frame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Patient acceptability of acupuncture treatment [ Time Frame: 72 hours after the ED discharge ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: Standard ED management alone
Experimental: 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.
Procedure: Acupuncture plus standard ED management

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013908

Contacts
Contact: Kun Hyung Kim, PhD +82-55-360-5908 pdchrist@gmail.com
Contact: Minjoo Kang, BcS +82-55-360-5907 syblkmj@hanmail.net

Locations
Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Kyungsangnamdo, Korea, Republic of, 626770
Contact: Kun Hyung Kim, PhD    +82-55-360-5971    pdchrist@gmail.com   
Contact: Dong Jin Kim, BcS    +82-55-360-5902    djkim085@gmail.com   
Principal Investigator: Gi Young Yang, PhD         
Principal Investigator: Ji Ho Ryu, PhD         
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Korea Institute of Oriental Medicine
Investigators
Principal Investigator: Gi Young Yang, PhD Korean Medicine Hospital, Pusan National University
Principal Investigator: Ji Ho Ryu, PhD Pusan National University Yangsan Hospital
  More Information

No publications provided

Responsible Party: Gi Young Yang, Assistant Professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT02013908     History of Changes
Other Study ID Numbers: ATPED
Study First Received: November 27, 2013
Last Updated: January 16, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Korean Medicine Hospital of Pusan National University:
acupuncture
emergency department
acute pain
ankle sprain
neck pain
primary headache

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Primary
Neck Pain
Emergencies
Headache
Ankle Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Leg Injuries
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 19, 2014