Clinical trial NCT01622959: Use of ACUPUNCTURE in Emergency Departement
Official title: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Department (ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age ≥18 Years
Presigned Consentement to Participate in the Study
Keywords: emergency departement
acute pain
acupuncture
morphine
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED.

In 1998, a United States National Institute of Health Consensus Conference Panel reviewed the status of acupuncture and concluded that: "There is sufficient evidence of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value." Similarly, in 2002, the World Health Organisation (WHO) stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness as analgesia has been established in controlled clinical studies.

Notwithstanding these difficulties, it has been shown that acupuncture analgesia in the treatment of chronic pain is comparable to morphine and that its better safety profile and lack of dependence makes it the preferred method of choice for these conditions.

There are very few clinical trials of acupuncture for acute pain to inform clinical practice; that's why we have the idea to do this study in our emergency department.

Detailed description: The objective is to evaluate the efficacy and the tolerance of acupuncture compared to intravenous morphine in the management of acute pain.

The results will also identify the impact that acupuncture treatment may have upon health resource utilization in the ED setting.

It is a randomized, prospective, controlled, conducted into emergency department. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).

In all included we recorded at baseline :

Age, sex, job, comorbidity, hour of beginning of pain. Injury nature and severity assessed by the Injury Severity Score (ISS) Mechanism of the injury and radiologic findings. VAPS : 0-100%

Eligibility criteria: Inclusion Criteria:

* Traumatic and non traumatic acute (\<72 hours) musculoskeletal pain with visual analog pain scale ( VAS or NRS ) \> 40 (on a scale 0-100)
* Age ≥18 years
* Presigned consentement to participate in the study.
* no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity); shoulder and elbow tendonitis; upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit; acute abdominal pain with no urgent surgical intervention including renal colic and dysmenorrhea; and acute headache .

Exclusion Criteria:

* Temperature \> 37.7° C,
* Anticoagulation medication use or the presence of a mechanical heart valve,
* Skin infections that would preclude certain acupuncture points being used,
* Refusal, inability to consent or communication difficulties,
* Acute major trauma,
* Any form of analgesia up to 60 minutes prior to study start,
* An initial pain score ≤ 40 on the pain scale (score range 0-100),
* Opiate contraindication,
* Pregnancy,
* Presentation to the ED \> 4 times in the previous 3 months with the same condition.

Primary outcomes:
measure: analgisia effect of acupuncture
timeFrame: one year
Secondary outcomes:
measure: use of acupuncture in emergency departement
timeFrame: one year
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Departement
Study officials:
affiliation: University of Monastir
name: nouira semir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R; STandards for Reporting Interventions in Controlled Trails of Acupuncture. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture. Acupunct Med. 2002 Mar;20(1):22-5. doi: 10.1136/aim.20.1.22.