Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000104055
Ethics application status
Approved
Date submitted
27/01/2010
Date registered
2/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does ear acupuncture relieve pain and anxiety in emergency department patients?
Scientific title
Does ear acupuncture relieve pain and anxiety in Emergency Department patients with hip and wrist injuries
Secondary ID [1] 1363 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
wrist injury 256642 0
hip injury 256643 0
pain 256736 0
anxiety 256737 0
Condition category
Condition code
Alternative and Complementary Medicine 256804 256804 0 0
Other alternative and complementary medicine
Injuries and Accidents 256890 256890 0 0
Other injuries and accidents
Anaesthesiology 256891 256891 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 Ear Acupuncture: insertion of Vinco press needles into 2 predefined auricular acupuncture points on ear ipsilateral to site of injury upon presentation to emergency care centre. These points have been traditionally used to treat pain and anxiety.Ear is then covered with an opaque bandage and needles are left in for a minimum of 15 minutes.
Intervention code [1] 255880 0
Treatment: Other
Comparator / control treatment
Group 2 Sham Acupuncture: insertion of Vinco press needles into 2 predefined auricular acupuncture points on ear ipsilateral to site of injury upon presentation to emergency care centre. These points have been traditionally used to treat stomach problems.Ear is then covered with an opaque bandage and needles are left in for a minimum of 15 minutes.

Group 3 Control: There are no press needles inserted.Ear is covered with an opaque bandage on the side ipsilateral to the injury.
Control group
Placebo

Outcomes
Primary outcome [1] 257669 0
>20mm decrease in pain on 100mm Visual Analogue Scale (VAS)
Timepoint [1] 257669 0
15-30 minutes after intervention
Primary outcome [2] 257670 0
>20mm decrease in anxiety on 100mm VAS
Timepoint [2] 257670 0
15m-30m after intervention
Secondary outcome [1] 262977 0
patient satisfaction via short phone administered questionaire
Timepoint [1] 262977 0
7 days post discharge

Eligibility
Key inclusion criteria
Adults presenting to Emergency Medicine at either North Shore or Waitakere Hospital Emergency Care Centre with painful suspected hip fracture or lower arm injury.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Triage category 1
Inability to give informed consent
Bleeding disorder, coagulopathy or taking warfarin
Ipsilateral ear injury or skin infection
Known sticking plaster allergy
Staff feel patient too unwell to participate

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)
Sequentially numbered opaque envelopes will be used . These are generated for each site before patient recruitment begins. As there are 3 study groups (Group 1,Group 2, Group 3) there are 3 corresponding ear diagrams which will be placed into the sequentially numbered opaque envelopes based on the outcome of the random number table. Group 1 shows ear acupuncture points used for pain and anxiety. Group 2 shows ear acupuncture points unrelated to pain or anxiety. Group 3 shows no points.
Once informed consent is obtained, the Researcher A will allocate the participant to the next sequential study number, the envelope will be opened and Researcher A will carry out the needle insertions and/or bandaging based on the diagram.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random number generator with blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
138
Accrual to date
Final
Recruitment outside Australia
Country [1] 2432 0
New Zealand
State/province [1] 2432 0

Funding & Sponsors
Funding source category [1] 256367 0
Hospital
Name [1] 256367 0
Waitemata District Health Board
Country [1] 256367 0
New Zealand
Primary sponsor type
Individual
Name
Dr Kim Yates
Address
Emergency Care Centre
North Shore Hospital
Private Bag 93503
Takapuna
Country
New Zealand
Secondary sponsor category [1] 251684 0
Hospital
Name [1] 251684 0
Waitemata District Health Board
Address [1] 251684 0
North Shore Hospital
Private Bag 93503
Takapuna
Country [1] 251684 0
New Zealand
Other collaborator category [1] 1051 0
Individual
Name [1] 1051 0
Mike Armour
Address [1] 1051 0
Emergency Care Centre
North Shore Hospital
Private Bag 93503
Takapuna
Country [1] 1051 0
New Zealand
Other collaborator category [2] 1052 0
Individual
Name [2] 1052 0
Willem Landman
Address [2] 1052 0
Emergency Care Centre
North Shore Hospital
Private Bag 93503
Takapuna
Country [2] 1052 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258437 0
Northern Y Regional Ethics Comittee
Ethics committee address [1] 258437 0
Ethics committee country [1] 258437 0
New Zealand
Date submitted for ethics approval [1] 258437 0
Approval date [1] 258437 0
Ethics approval number [1] 258437 0

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

Contacts
Principal investigator
Name 30743 0
Address 30743 0
Country 30743 0
Phone 30743 0
Fax 30743 0
Email 30743 0
Contact person for public queries
Name 13990 0
Dr Kim Yates
Address 13990 0
Emergency Care Centre
North Shore Hospital
Private Bag 93503
Takapuna
Country 13990 0
New Zealand
Phone 13990 0
+6498381726
Fax 13990 0
Email 13990 0
Kim.Yates@WaitemataDHB.govt.nz
Contact person for scientific queries
Name 4918 0
Dr Kim Yates
Address 4918 0
Emergency Care Centre
North Shore Hospital
Private Bag 93503
Takapuna
Country 4918 0
New Zealand
Phone 4918 0
+6498381726
Fax 4918 0
Email 4918 0
Kim.Yates@WaitemataDHB.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.