Battle Field (Ear) Acupuncture as an adjunct to treat pain of the abdomen, limb trauma and lower back in the emergency department - a pilot study.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: Arm 1 Ten ASP (Aigulle Acupuncture semi‐Permanent) gold needles inserted according to the Battlefield ear acupuncture protocol (5 needles each ear i.e. cingulate gyrus, thalamus, omega, point zero and Shenmen), needles concealed with 10 DuoDerm tapes and then also receive standard analgesia care (see below). Acupuncture practitioners will be usual health care providers i.e. non‐acupuncturists (emergency doctors, nurse practitioners, registered nurses) trained by the principal investigator (a registered medical acupuncturist). Reference Battlefield ear acupuncture protocol: Niemtzow RC. Battlefield acupuncture. Medical Acupuncture. 2007 Dec 1;19(4):225‐8. Note: Duoderm tapes are cut into approximately 1cm squares with a central mark to obscure needle. Product information on extra thin Duoderm dressings can be obtained from: https://www.convatec.com.au/advanced‐wound‐care/duoderm‐dressings/duoderm‐extra‐thin‐dressing/ Arm 2 The second arm or sham group will have a piezoelectric device (Pulsar Plus Piezo Stimulator) sounded adjacent (1‐2cm) to but not onto the ear. Normally the piezo stimulator generates a single electric impulse by compressing and releasing pressure on a piezo crystal inside the stimulator. However, because it is only activated in the air away from the patient, no electric current enters the patient and the only perceived intervention is a clicking sound ‐ hence used as our sham device. 10 DuoDerm tapes will be applied similarly to the needle intervention arm and then will also receive standard analgesia care (see below). Product information on the Pulsar Plus Piezo Stimulator can be obtained from: https://www.heliosupply.com.au/index.php/electro‐laser/stimulators‐point‐locators/electrical‐leads‐wq001‐2.html Arm 3 The third arm is the standard analgesia care group alone. This group will have standard analgesia care and 10 DuoDerm tapes also applied. Standard usual analgesic care consists of: Patients with a NPRS‐10 gre CONDITION: abdominal pain;limb trauma pain ;low back pain; ; abdominal pain ; limb trauma pain ; low back pain Anaesthesiology ‐ Pain management Emergency medicine ‐ Other emergency care PRIMARY OUTCOME: The mean numerical pain rating scale out of 10 (NPRS‐10) at rest for the three groups will be compared.[Triage, Post tapes (i.e. immediately post intervention /sham /tapes only for SAC), 1 and 2 hours post‐intervention.] SECONDARY OUTCOME: Adverse effects using a spontaneous (unsolicited) reporting method will be collected using a non‐structured open‐ended question for either intervention (acupuncture or sham) or pharmacological analgesia. ; Reference: Wernicke JF, Faries D, Milton D, Weyrauch K. Detecting Treatment Emergent Adverse Events in Clinical Trials. Drug safety. 2005 Nov 1;28(11):1057‐63. ; [2 hours post‐intervention] Costings: Will include prices (AUD) of analgesics and needles used. Analgesics used during the 2‐hour time period will be obtained from the medical record and prices calculated from analgesia imprest costs provided by the private pharmacy supplier for the ED. Acupuncture needle costs (fixed at 10 needles per patient) will be obtained from the private acupuncture supplier. ; [2 hours post‐intervention] Number needed to treat (NNT) to obtain a 30% drop in NPRS‐10 from baseline compared to sham ; that which decreases the triage pain score by greater than or equal to 2 and to a level less than 4). ; ; [2 hours post‐intervention] ; [Post tapes (i.e. immediately post intervention /sham /tapes only for SAC), 1 and 2 hours post‐intervention.] Patient satisfaction using a six‐point Likert scale.[ 2 hours post‐intervention ] Percentage of group with 'adequate analgesia' (a decrease in the NPRS‐10 is defined as ; [Post tapes (i.e. immediately post intervention /sham /tapes only for SAC), 1 and 2 hours post‐intervention.] Time taken to apply ear acupuncture or sham using a stopwatch[post triage] Total oral morphine equivalent opioid dose (milligrams) in 2 hours from intervention. ; Total opioids administered within the 2‐hour frame from intervention obtained retrospectively (post attendance) from the patient's drug chart (hospital record) and will be calculated by converting the dosage of the various administered opioids in that 2 hour time frame to a oral morphine dose (milligrams) equivalent. The Faculty of Pain Medicine ANZCA opioid dose converter which is an evidence‐based and authoritative opioid conversion application will be used i.e. http://www.opioidcalculator.com.au/ INCLUSION CRITERIA: Patients attending the emergency department with acute pain (a NPRS‐10 greater than or equal to 4 at rest) of the: lower back, abdominal condition, or limb trauma, triage categories 3‐5
Epistemonikos ID: 9bb5c114c45bb062a0e1cb12935cb989dcbcd092
First added on: Aug 24, 2024