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Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department (AcuMAP)

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acupuncture
Morphine titration
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring acupuncture, morphine, acute pain

Eligibility Criteria

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

Inclusion Criteria:

  • Acute onset pain < 72 hours of the ED presentation
  • Pain intensity ≥ 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain)
  • Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit.
  • Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea.
  • Acute headache that meets the criteria of primary headache, as described by the international headache society.

Exclusion Criteria:

  • Temperature > 37.7°c
  • Violent mechanism of trauma
  • Patients under anticoagulant drugs or with coagulation abnormalities
  • Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points
  • Patients that were judged enable to participate in the study at the discretion of the treating physician.
  • Refusal, inability to consent.
  • Inability to assess the degree of pain using the VAS or NRS
  • Patients who had received analgesics in the 6 hours prior to the enrollment
  • An initial pain score ≤ 40 on the VAS or NRS
  • Patients who had presented to the ED in the last 24 hours with the same motif
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Acupuncture

    IV Morphine

    Arm Description

    patients received a 20 to 30 minutes session of acupuncture

    patients received an intravenous titration of morphine every 5 minutes.

    Outcomes

    Primary Outcome Measures

    change of pain severity from baseline
    Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol. Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead. Success of treatment was defined by a drop in the pain intensity under 30.

    Secondary Outcome Measures

    resolution time
    This interval was defined by the time (in minutes) elapsed between the start of the protocol (T0) and the decrease of the pain score of at least 50% of its initial value.
    adverse events
    Occurrence of major side effects implicates the immediate ending of the protocol, more particularly: Allergic manifestations such as rush and generalized edema severe hypotension defined by a drop of the systolic blood pressure under 90 mmHg or a loss of more than 20 mmHg of the initial systolic blood pressure recurrent vomiting non controlled by the standard measures Altered mental status Uncontrolled bleeding from the site of needle insertion Respiratory distress with capillary saturation under 95% or signs of pneumothorax

    Full Information

    First Posted
    May 25, 2015
    Last Updated
    February 20, 2020
    Sponsor
    University of Monastir
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460913
    Brief Title
    Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department
    Acronym
    AcuMAP
    Official Title
    Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Monastir

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still scarce.
    Detailed Description
    Pain is a common cause of emergency department visits and its control remains a challenge and health priority worldwide. Many techniques were developed to control pain and to ensure patients comfort but their application is still difficult especially in emergency department (ED) settings, due to the variety of treated conditions, the non-availability of qualified practitioners and the patient's specificity. Pharmacologic methods in particular IV opioids are the most used and with regard to their rapid action with high efficacy. But the use of these drugs can be limited by their side effects. Non-pharmacologic pain relief techniques such as acupuncture have been proposed. During the second half of the twentieth century, acupuncture was established in Europe and in the last two decades, it has spread around the world. In Tunisia, acupuncture was introduced into the health system in the 90s, particularly to treat pain. The World Health Organization (WHO) has recognized acupuncture as safe and sound therapy. A preliminary list of acupuncture indications has been reported including 43 diseases. However, the introduction of acupuncture in the treatment of pain in ED is more recent or even anecdotal. In the treatment of chronic pain, it was shown that acupuncture is comparable to morphine and that its better safety profile makes it the method of choice in some clinical conditions. In a recent systematic review, it has been concluded that there is insufficient evidence for the use of acupuncture in the ED settings due to the paucity of randomized controlled trials and the suboptimal methodological qualities of related studies. The aim of our study was to evaluate the efficacy and safety of acupuncture compared with morphine for the management of acute pain in ED.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain
    Keywords
    acupuncture, morphine, acute pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Experimental
    Arm Description
    patients received a 20 to 30 minutes session of acupuncture
    Arm Title
    IV Morphine
    Arm Type
    Active Comparator
    Arm Description
    patients received an intravenous titration of morphine every 5 minutes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Acupuncture session of 20 to 30 minutes. Treatment protocols were determined through review of major clinical manuals and textbooks, literature review, and a panel of specialist acupuncturists from Chinese medicine backgrounds.
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine titration
    Other Intervention Name(s)
    Morphine
    Intervention Description
    Patients in this group received IV titrated morphine. Morphine was prepared onsite and diluted in a manner to obtain a dose of 1mg in each ml of normal saline. The initial dose was 0.1 mg per kg and a titration dose of 0.05 mg per Kg was repeated every 5 minutes until reaching objective. The maximum allowed dose was 1.5 mg/kg.
    Primary Outcome Measure Information:
    Title
    change of pain severity from baseline
    Description
    Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol. Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead. Success of treatment was defined by a drop in the pain intensity under 30.
    Time Frame
    10, 20, 30, 45, 60 minutes
    Secondary Outcome Measure Information:
    Title
    resolution time
    Description
    This interval was defined by the time (in minutes) elapsed between the start of the protocol (T0) and the decrease of the pain score of at least 50% of its initial value.
    Time Frame
    10, 20, 30, 45, 60 minutes
    Title
    adverse events
    Description
    Occurrence of major side effects implicates the immediate ending of the protocol, more particularly: Allergic manifestations such as rush and generalized edema severe hypotension defined by a drop of the systolic blood pressure under 90 mmHg or a loss of more than 20 mmHg of the initial systolic blood pressure recurrent vomiting non controlled by the standard measures Altered mental status Uncontrolled bleeding from the site of needle insertion Respiratory distress with capillary saturation under 95% or signs of pneumothorax
    Time Frame
    10, 20, 30, 45, 60 minutes and until ED discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute onset pain < 72 hours of the ED presentation Pain intensity ≥ 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain) Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit. Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea. Acute headache that meets the criteria of primary headache, as described by the international headache society. Exclusion Criteria: Temperature > 37.7°c Violent mechanism of trauma Patients under anticoagulant drugs or with coagulation abnormalities Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points Patients that were judged enable to participate in the study at the discretion of the treating physician. Refusal, inability to consent. Inability to assess the degree of pain using the VAS or NRS Patients who had received analgesics in the 6 hours prior to the enrollment An initial pain score ≤ 40 on the VAS or NRS Patients who had presented to the ED in the last 24 hours with the same motif Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nouira semir, MD
    Organizational Affiliation
    University of Monastir
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23374207
    Citation
    Kim KH, Lee BR, Ryu JH, Choi TY, Yang GY. The role of acupuncture in emergency department settings: a systematic review. Complement Ther Med. 2013 Feb;21(1):65-72. doi: 10.1016/j.ctim.2012.12.004. Epub 2012 Dec 29.
    Results Reference
    background
    PubMed Identifier
    22085683
    Citation
    Cohen M, Parker S, Taylor D, Smit de V, Ben-Meir M, Cameron P, Xue C. Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial. Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241.
    Results Reference
    background

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    Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department

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