Age =18 Years Clinical Trial
Official title:
Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Department (ED)
| Verified date | January 2020 |
| Source | University of Monastir |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | June 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Tunisia | Emergency Departement | Monastir |
| Lead Sponsor | Collaborator |
|---|---|
| University of Monastir |
Tunisia,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | analgisia effect of acupuncture | subjuctive outcome | one year | |
| Secondary | use of acupuncture in emergency departement | objective outcome | one year |