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Use of ACUPUNCTURE in Emergency Departement

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Tunisia

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Age ≥18 Years focused on measuring emergency departement, acute pain, acupuncture, morphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Emergency Departement

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

acupuncture

morphine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

analgisia effect of acupuncture

subjuctive outcome

Secondary Outcome Measures

use of acupuncture in emergency departement

objective outcome

Full Information

NCT ID

NCT01622959

First Posted

June 15, 2012

Last Updated

January 28, 2020

Sponsor

University of Monastir

1. Study Identification

Unique Protocol Identification Number

NCT01622959

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

April 2012 (Actual)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

emergency departement, acute pain, acupuncture, morphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acupuncture

Arm Type

Active Comparator

Arm Description

Arm Title

morphine

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Intervention Description

-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 Measure Information:

Title

analgisia effect of acupuncture

Description

subjuctive outcome

Time Frame

one year

Secondary Outcome Measure Information:

Title

use of acupuncture in emergency departement

Description

objective outcome

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nouira semir, MD

Organizational Affiliation

University of Monastir

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emergency Departement

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

12. IPD Sharing Statement

Citations:

PubMed Identifier

11926601

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.

Results Reference

background

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Use of ACUPUNCTURE in Emergency Departement

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