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Use of ACUPUNCTURE in Emergency Departement

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ClinicalTrials.gov Identifier: NCT01622959
Recruitment Status : Unknown
Verified September 2013 by Nouira, University of Monastir.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : September 12, 2013
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir

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.


Condition or disease Intervention/treatment Phase
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 Procedure: Acupuncture Not Applicable

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%


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Department (ED)
Study Start Date : June 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Active Comparator: acupuncture

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

-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.


Sham Comparator: morphine
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.





Primary Outcome Measures :
  1. analgisia effect of acupuncture [ Time Frame: one year ]
    subjuctive outcome


Secondary Outcome Measures :
  1. use of acupuncture in emergency departement [ Time Frame: one year ]
    objective outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622959


Contacts
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Contact: Nouira Semir, MD 216 73532014 semir.nouira@rns.tn

Locations
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Tunisia
Emergency Departement Not yet recruiting
Monastir, Tunisia, 5000
Contact: semir nouira, professor    21673461144    semir.nouira@rns.tn   
Principal Investigator: semir nouira, professor         
Sub-Investigator: houda baccouche, resident         
Emergency Departement Not yet recruiting
Monastir, Tunisia, 5000
Contact: semir nouira, professor    21673461144    semir.nouira@rns.tn   
Fattouma Bourguiba University Hospital Recruiting
Monastir, Tunisia, 5000
Contact: Nouira Semir, MD    216 73532014    semir.nouira@rns.tn   
Sponsors and Collaborators
University of Monastir

Publications:
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Responsible Party: Nouira, professor, University of Monastir
ClinicalTrials.gov Identifier: NCT01622959     History of Changes
Other Study ID Numbers: use of ACUPUNCTURE in ED
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Nouira, University of Monastir:
emergency departement
acute pain
acupuncture
morphine

Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents