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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 information initially 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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 533 0
University
Name [1] 533 0
RMIT University
Address [1] 533 0
225-245 Plenty Rd, Bundoora VIC, Australia, 3083
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
RMIT Bundoora West campus, Plenty Road, Bundoora, VIC
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
This prospective, randomised, patient/assessor blinded, sham-acupuncture controlled clinical trial was conducted at the Clinical Trial Lab of the School of Health sciences, WHO Collaborating Centre for Traditional Medicine, RMIT University, Australia, with the approval of the Human Research Ethics Committee of the RMIT University (Project No. 16/05), . Fifty (50) participants out of 179 enquires were enrolled and randomly allocated into either the real acupuncture (n=26) or the sham acupuncture (n=24) groups.
Trial website
Trial related presentations / publications
Wang, Y, Xue, C, Helme, R, Da Costa, C and Zheng, Z 2015, 'Acupuncture for frequent migraine: A randomized, patient/assessor blinded, controlled trial with one-year follow-up', Evidence-Based Complementary and Alternative Medicine, vol. 2015, 920353, pp. 1-14.
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
impness@hotmail.com
Contact person for public queries
Name 9418 0
Prof 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
charlie.xue@rmit.edu.au
Contact person for scientific queries
Name 346 0
A/Prof 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
zhen.zheng@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic and clinical data
When will data be available (start and end dates)?
The data is available from 2008 for 15 years.
Available to whom?
The group data is available for the public from the publication.
The individual data is available for individual participants.
Available for what types of analyses?
All clinical trial data including drop-out participants are available for either intended-to-treat or Per protocol analysis.
How or where can data be obtained?
The raw data and summarized electrical data are both kept in the RMIT University.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5930 0
Wang, Y, Xue, C, Helme, R, Da Costa, C and Zheng, Z 2015, 'Acupuncture for frequent migraine: A randomized, patient/assessor blinded, controlled trial with one-year follow-up', Evidence-Based Complementary and Alternative Medicine, vol. 2015, 920353, pp. 1-14.
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary