Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000314628
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
6/09/2005
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Date results provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and safety of acupuncture for migraine: a randomised, single blind and sham controlled trial
Scientific title
Evaluation of effectiveness and safety of acupuncture in the treatment of migraine: a randomised, single blind and sham controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic migraine 402 0
Condition category
Condition code
Neurological 473 473 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be randomised into either real acupuncture or sham acupuncture group to receive 16 sessions of treatment over a period of 20 weeks.
Intervention code [1] 229 0
None
Comparator / control treatment
Sham acupuncture
Control group
Placebo

Outcomes
Primary outcome [1] 538 0
Frequency of migraine attacks between the two groups
Timepoint [1] 538 0
Primary outcome [2] 539 0
Duration of migraine attacks between the two groups
Timepoint [2] 539 0
Primary outcome [3] 540 0
Intensity of migraine attacks between the two groups
Timepoint [3] 540 0
Primary outcome [4] 541 0
Relief medication between the two groups
Timepoint [4] 541 0
Secondary outcome [1] 1143 0
Migraine Specific Quality of Life (MSQOL)
Timepoint [1] 1143 0
Assessed once every four weeks.
Secondary outcome [2] 1144 0
Heat and pressure pain thresholds.
Timepoint [2] 1144 0
Tested twice at baseline and after treatment respectively.

Eligibility
Key inclusion criteria
Current history of migraine symptoms; and provision of written consent to participante.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pregnancy or malignancy; had acupuncture treatment in the previous 6 months; history of head injury or whiplash; severe arrhythmia or heart filure, brain tumour or epilepsy; and haemophiliac.

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)
sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using Study manager, a clinical trial software package to generate the random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
sham for control group
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2005
Actual
9/12/2005
Date of last participant enrolment
Anticipated
Actual
1/12/2006
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
78
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 533 0
University
Name [1] 533 0
RMIT University
Country [1] 533 0
Australia
Primary sponsor type
University
Name
RMIT Chinese Medicine Research Group
Address
RMIT Chinese Medicine Research Group
School of Health and Biomedical Sciences
225-245 Plenty Rd, Bundoora
VIC, Australia, 3083
Country
Australia
Secondary sponsor category [1] 433 0
None
Name [1] 433 0
N/A
Address [1] 433 0
Country [1] 433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1533 0
Chinese Medicine Clinical Trial Laboratory
Ethics committee address [1] 1533 0
Ethics committee country [1] 1533 0
Australia
Date submitted for ethics approval [1] 1533 0
Approval date [1] 1533 0
01/07/2005
Ethics approval number [1] 1533 0

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

Contacts
Principal investigator
Name 35364 0
Dr Yanyi Wang
Address 35364 0
Division of Chinese Medicine School of Health Science RMIT University PO Box 71 Bundoora VIC 3083
Country 35364 0
Australia
Phone 35364 0
+61 3 9925 7167
Fax 35364 0
Email 35364 0
[email protected]
Contact person for public queries
Name 9418 0
A/Prof. Charlie Xue
Address 9418 0
Division of Chinese Medicine School of Health Science RMIT University PO Box 71 Bundoora VIC 3083
Country 9418 0
Australia
Phone 9418 0
+61 3 9925 7360
Fax 9418 0
+61 3 99257178
Email 9418 0
[email protected]
Contact person for scientific queries
Name 346 0
Dr. Zhen Zheng
Address 346 0
Division of Chinese Medicine School of Health Science RMIT University PO Box 71 Bundoora VIC 3083
Country 346 0
Australia
Phone 346 0
+61 3 99257176
Fax 346 0
+61 3 99257178
Email 346 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The group data is available for the public from the publication.
The individual data is available for individual participants.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Demographic and clinical data

What types of analyses could be done with individual participant data?
• All clinical trial data including drop-out participants are available for either intended-to-treat or Per protocol analysis.

When can requests for individual participant data be made (start and end dates)?
From:
The data is available from 2008 for 15 years.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• The raw data and summarized electrical data are both kept in the RMIT University.

Are there extra considerations when requesting access to individual participant data?
No


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
SourceTitleYear of PublicationDOI
EmbaseHas acupuncture benefit in the management of migraine? A scoping review.2022https://dx.doi.org/10.1016/j.acu.2021.100167
N.B. These documents automatically identified may not have been verified by the study sponsor.