Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000483651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
2/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of acupuncture for the treatment of acute ankle sprains in the emergency department: a pilot study
Scientific title
The use of acupuncture for the treatment of acute ankle sprains in the emergency department: a randomised control trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ankle sprain 605 0
Condition category
Condition code
Injuries and Accidents 677 677 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single treatment with acupuncture for ankle sprains as they present to the emergency department.
Intervention code [1] 536 0
Treatment: Other
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 818 0
Decrease in pain and therefore less analgesia requirements
Timepoint [1] 818 0
Primary outcome [2] 819 0
Functional capacity improvement
Timepoint [2] 819 0
Secondary outcome [1] 1629 0
May facilitate improvement of symptoms.
Timepoint [1] 1629 0

Eligibility
Key inclusion criteria
Adults with actue ankle sprain (less than 24hrs), able to consent, willing to receive acupuncture and recording pain,analgesia and functional scores.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion of children and those unable to consent, if they have contraindications to acupunture such as anticoagulation (warfarin), pregnant, epileptic or have prosthetic valves.

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)
randomised concealed precoded envelopes with either conventional therapy or conventional therapy plus single treatment acupuncture
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using a random number table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1656 0
3076

Funding & Sponsors
Funding source category [1] 749 0
Self funded/Unfunded
Name [1] 749 0
Michelle Mok
Country [1] 749 0
Australia
Primary sponsor type
Individual
Name
Dr Michelle Mok
Address
Country
Secondary sponsor category [1] 620 0
Hospital
Name [1] 620 0
The Northern Hospital
Address [1] 620 0
185 Cooper St Epping Victoria 3076 Australia
Country [1] 620 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1968 0
The Northern Hospital Ethics Committee
Ethics committee address [1] 1968 0
185 Cooper St Epping 3076 Victoria
Ethics committee country [1] 1968 0
Australia
Date submitted for ethics approval [1] 1968 0
Approval date [1] 1968 0
21/11/2005
Ethics approval number [1] 1968 0

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

Contacts
Principal investigator
Name 35633 0
Address 35633 0
Country 35633 0
Phone 35633 0
Fax 35633 0
Email 35633 0
Contact person for public queries
Name 9725 0
Michelle Mok
Address 9725 0
The Northern Hospital
185 Cooper St
Epping VIC 3086
Country 9725 0
Australia
Phone 9725 0
+61 3 84058600
Fax 9725 0
+61 3 84058994
Email 9725 0
[email protected]
Contact person for scientific queries
Name 653 0
Michelle Mok
Address 653 0
The Northern Hospital
185 Cooper St
Epping VIC 3086
Country 653 0
Australia
Phone 653 0
+61 3 84058600
Fax 653 0
+61 3 84058994
Email 653 0
[email protected]

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.