Acute Pain Clinical Trial
— AcuMAPOfficial title:
Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study
NCT number | NCT02460913 |
Other study ID # | 13/02 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | March 2013 |
Verified date | February 2020 |
Source | University of Monastir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still scarce.
Status | Completed |
Enrollment | 300 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Acute onset pain < 72 hours of the ED presentation - Pain intensity = 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain) - Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit. - Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea. - Acute headache that meets the criteria of primary headache, as described by the international headache society. Exclusion Criteria: - Temperature > 37.7°c - Violent mechanism of trauma - Patients under anticoagulant drugs or with coagulation abnormalities - Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points - Patients that were judged enable to participate in the study at the discretion of the treating physician. - Refusal, inability to consent. - Inability to assess the degree of pain using the VAS or NRS - Patients who had received analgesics in the 6 hours prior to the enrollment - An initial pain score = 40 on the VAS or NRS - Patients who had presented to the ED in the last 24 hours with the same motif - Pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Monastir |
Cohen M, Parker S, Taylor D, Smit de V, Ben-Meir M, Cameron P, Xue C. Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial. Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241. — View Citation
Kim KH, Lee BR, Ryu JH, Choi TY, Yang GY. The role of acupuncture in emergency department settings: a systematic review. Complement Ther Med. 2013 Feb;21(1):65-72. doi: 10.1016/j.ctim.2012.12.004. Epub 2012 Dec 29. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of pain severity from baseline | Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol. Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead. Success of treatment was defined by a drop in the pain intensity under 30. |
10, 20, 30, 45, 60 minutes | |
Secondary | resolution time | This interval was defined by the time (in minutes) elapsed between the start of the protocol (T0) and the decrease of the pain score of at least 50% of its initial value. | 10, 20, 30, 45, 60 minutes | |
Secondary | adverse events | Occurrence of major side effects implicates the immediate ending of the protocol, more particularly: Allergic manifestations such as rush and generalized edema severe hypotension defined by a drop of the systolic blood pressure under 90 mmHg or a loss of more than 20 mmHg of the initial systolic blood pressure recurrent vomiting non controlled by the standard measures Altered mental status Uncontrolled bleeding from the site of needle insertion Respiratory distress with capillary saturation under 95% or signs of pneumothorax |
10, 20, 30, 45, 60 minutes and until ED discharge |
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