Use of ACUPUNCTURE in Emergency Departement

NCT01622959 | Completed DMC

• 1 other identifier: use of ACUPUNCTURE in ED
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Age ≥18 Years; Presigned Consentement to Participate in the Study

Keywords

emergency departement; acute pain; acupuncture; morphine

Outcome Measures

Primary Outcomes (1)

• analgisia effect of acupuncture

  subjuctive outcome

  one year

Secondary Outcomes (1)

• use of acupuncture in emergency departement

  one year

Study Arms (2)

acupuncture

ACTIVE COMPARATOR

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

morphine

SHAM COMPARATOR

drug:5mg of morphine followed by intravenous administration of 2,5 mg morphine each 5 min, until VAPS becomes \<30%.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

-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.

acupuncture; morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Emergency Departement

Monastir, 5000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 11926601 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• nouira semir, MD

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

TU (1)