Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000051145
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
15/01/2019
Date last updated
16/04/2021
Date data sharing statement initially provided
15/01/2019
Date results provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 295728 0
Nil known
Universal Trial Number (UTN)
U1111-1218-5037
Trial acronym
EDEA
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
abdominal pain 309127 0
limb trauma pain 309128 0
low back pain 309129 0
Condition category
Condition code
Emergency medicine 308002 308002 0 0
Other emergency care
Anaesthesiology 309661 309661 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 greater or equal to 4 and less than or equal to 7 will receive paracetamol 1g orally / intravenously and Ibuprofen 400-800mg orally or Ketorolac 10mg intravenously / 15mg intramuscularly pending last dose of relevant / same analgesic.
Rescue medication is oral / under the tongue opioid after 30 minutes’ post triage: Oxycodone 5-10mg orally, Buprenorphine 200-400mcg under the tongue or Tapentadol IR 50 – 100mg orally. Antiemetic if nauseated

Patients with a NPRS-10 > 7 will receive above regime for paracetamol / non-steroidal anti-inflammatory and rapid acting opioid: Fentanyl 1.5mcg/Kg/dose intranasally – max 2 doses or intravenously, Fentanyl 25mcg boluses to 100mcg total intravenously or Morphine 1-2.5mg boluses to 10mg total intravenously. Further rescue doses of Fentanyl intravenously, Morphine intravenously and Oxycodone 5-10mg orally. Antiemetic if nauseated

The expected duration of application of the ear needles per patient is approximately 4 minutes. This application time is a secondary outcome. Needles will remain in situ for 2 hours and then removed.
Intervention code [1] 302052 0
Treatment: Other
Comparator / control treatment
Arm 2
The Sham group will have the Piezoelectric device sounded adjacent to but not onto the ear. 10 DuoDerm tapes will be applied similarly to the intervention arm. Then standard analgesia care will be administered.
Arm 3
This is the standard analgesia care group alone. This group will have standard analgesia care and 10 DuoDerm tapes also applied.
Control group
Placebo

Outcomes
Primary outcome [1] 306994 0
The mean numerical pain rating scale out of 10 (NPRS-10) at rest for the three groups will be compared.
Timepoint [1] 306994 0
Triage, Post tapes (i.e. immediately post intervention /sham /tapes only for SAC), 1 and 2 hours post-intervention.
Secondary outcome [1] 350310 0
Percentage of group with 'adequate analgesia' (a decrease in the NPRS-10 is defined as
that which decreases the triage pain score by greater than or equal to 2 and to a level less than 4).
Timepoint [1] 350310 0
Post tapes (i.e. immediately post intervention /sham /tapes only for SAC), 1 and 2 hours post-intervention.
Secondary outcome [2] 350495 0
Number needed to treat (NNT) to obtain a 30% drop in NPRS-10 from baseline compared to sham
Timepoint [2] 350495 0
Post tapes (i.e. immediately post intervention /sham /tapes only for SAC), 1 and 2 hours post-intervention.
Secondary outcome [3] 350496 0
Patient satisfaction using a six-point Likert scale.
Timepoint [3] 350496 0
2 hours post-intervention
Secondary outcome [4] 350497 0
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/
Timepoint [4] 350497 0
2 hours post-intervention
Secondary outcome [5] 350498 0
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.
Timepoint [5] 350498 0
2 hours post-intervention
Secondary outcome [6] 350499 0
Time taken to apply ear acupuncture or sham using a stopwatch
Timepoint [6] 350499 0
post triage
Secondary outcome [7] 350500 0
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.
Timepoint [7] 350500 0
2 hours post-intervention

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Triage category 1 or 2
• Unable to comprehend consent due to a barrier in language (eg failure to access a quality translator) or cognition
• Immediate medical intervention required
• Pregnant
• Chronic pain (defined as on opioids and or pain is greater than 6 weeks’ duration)
• Chest pain
• Immune deficiency
• On anticoagulants such as warfarin, novel anticoagulants e.g. apixaban, dabigatran, rivaroxaban and anti-platelet agents clopidogrel, ticagrelor and prasugrel. Those on aspirin however, can be included.
• Artificial heart valve
• Permanent pacemaker
• Needle phobia
• Allergy to gold or tapes
• Known blood borne pathogen eg HIV, Hep C and Hep B antigen positive.
• Recent ear infection or trauma
• Deafness or uses hearing aids

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation will be allocated prior to the trial with opaque sealed envelopes placed in a draw on site and opened post consent to enter the trial. The envelopes will be marked: low back pain 1-30, abdominal pain 1-30 and limb trauma pain 1-30.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Ninety patients (30 from each pain condition) will be randomly allocated to one of the three treatment arms, such that each treatment arm comprises 10 patients from each pain condition, using a block size of six. The randomisation sequence will be determined using Stata (15.0 StataCorp™, College Station, TX, USA) by a statistician not involved in treatment allocation or data collection. Patients will only be invited to participate into the trial when a trained investigator is available.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will consist of using the independent Student’s t-test for continuous data and Chi-square for categorical data using the Stata software program. The continuous variables include: NPRS-10, morphine dose equivalent (mg).

Categorical variables will be used to compare the differences in proportions for demographics of the three treatment arms including sex, medical condition and age group. Non-parametric tests such as the Kruskall Wallis will be used to confirm results from the t test in case there is a violation of the normality assumption. Generalised Linear mixed models will be used to analyse NPRS-10s controlling for confounding variables such as time. Both parametric and non-parametric analysis will be performed on the satisfaction scores (six-point Likert scale). Costing will include prices of consumables and medications. Needling time will be compared to an approximated time taken for administration of opioids approximated from a prior audit. Data analysis will be blinded and using ‘intention to treat’ to avoid bias from any dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2019
Actual
18/01/2019
Date of last participant enrolment
Anticipated
19/01/2020
Actual
27/08/2019
Date of last data collection
Anticipated
19/01/2020
Actual
27/08/2019
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11632 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 23678 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 308351 0
Hospital
Name [1] 308351 0
Unfunded but research support from Emergency Department SJOG Murdoch
Country [1] 308351 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia (Fremantle)
Address
School of Medicine
The University of Notre Dame Australia
PO Box 1225
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 299751 0
Hospital
Name [1] 299751 0
St John of God Murdoch Hospital
Address [1] 299751 0
St John of God Murdoch Hospital
1 Barry Marshall Pde
Murdoch WA 6150
Country [1] 299751 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301130 0
SJGHC Human Research Ethics Committee
Ethics committee address [1] 301130 0
Ethics committee country [1] 301130 0
Australia
Date submitted for ethics approval [1] 301130 0
11/09/2018
Approval date [1] 301130 0
26/11/2018
Ethics approval number [1] 301130 0
1426

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85958 0
Prof Andrew Jan
Address 85958 0
Emergency Department
St John of God Hospital Murdoch
1 Barry Marshall Pde
Murdoch
WA 6150
Country 85958 0
Australia
Phone 85958 0
+61894389110
Fax 85958 0
+61894389152
Email 85958 0
[email protected]
Contact person for public queries
Name 85959 0
Andrew Jan
Address 85959 0
Emergency Department
St John of God Hospital Murdoch
1 Barry Marshall Pde
Murdoch
WA 6150
Country 85959 0
Australia
Phone 85959 0
+61894389110
Fax 85959 0
+61894389152
Email 85959 0
[email protected]
Contact person for scientific queries
Name 85960 0
Andrew Jan
Address 85960 0
Emergency Department
St John of God Hospital Murdoch
1 Barry Marshall Pde
Murdoch
WA 6150
Country 85960 0
Australia
Phone 85960 0
+61894389110
Fax 85960 0
+61894389152
Email 85960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
primary and secondary outcomes
When will data be available (start and end dates)?
21 January 2020 till 21 January 2023 being after the trial results have been accepted for publication and at least "in press", and release of data will be subject to formal approval from the SJOG ethics committee and meeting any requirements they may impose.
Available to whom?
Other trial investigators, journals receiving publication
Available for what types of analyses?
Checking primary and secondary outcomes
How or where can data be obtained?
Excel sheets


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
581Other    website: https://www.edeatrial.com.au/



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.