Clinical trial NCT02460913: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department
Official title: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Keywords: acupuncture
morphine
acute pain
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change of pain severity from baseline
timeFrame: 10, 20, 30, 45, 60 minutes
Secondary outcomes:
measure: resolution time
timeFrame: 10, 20, 30, 45, 60 minutes
measure: adverse events
timeFrame: 10, 20, 30, 45, 60 minutes and until ED discharge
Other outcomes:
Locations:
Study officials:
affiliation: University of Monastir
name: nouira semir, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.