An interventional study of Acupuncture in Age ≥18 Years and Presigned Consentement to Participate in the Study, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by University of Monastir · Not applicable, Interventional, and Treatment
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.
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%
1,692 studies on the registry are indexed under Emergencies; 332 are open to participants now.
This study's enrollment of 300 is above the median of 145 across 930 interventional studies indexed under Emergencies.
Browse Emergencies studies →University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inclusion criteria: Traumatic and non traumatic acute pain with visual analog pain scale ( VAPS) \> 40 (on a scale 0-100) Age ≥18 years Presigned consentement to participate in the study. 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.
Procedure: Acupuncture
drug:5mg of morphine followed by intravenous administration of 2,5 mg morphine each 5 min, until VAPS becomes \<30%.
Procedure: Acupuncture
-Group Acupuncture: Receiving protocol of acupuncture. Acupuncture is performed by a trained certificied resident. The protocols, which allow acupuncture points to be selected from a pool of pre-determined points for each condition, provide sufficient standardization to assist replication, yet are flexible enough to allow individualized treatments. These protocols also allow for additional points, such as 'ashi points', to be used at the discretion of the acupuncturist. The location of the points, angle of insertion and depth of insertion were sourced from a popular text 'A Manual of Acupuncture'. -Group Morphine: Receiving 5mg of morphine followed by intravenous administration of 2,5 mg morphine each 5 min, until VAPS becomes \<30%. Treatment failure is defined as VAPS\>30 %, 30min after beginning of the protocol. In this case, analgesic treatment was administered according to the treating physician discretion.
analgisia effect of acupuncture
subjuctive outcome
Time frame: one year
use of acupuncture in emergency departement
objective outcome
Time frame: one year
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of Monastir