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

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