Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000766617
Ethics application status
Approved
Date submitted
18/10/2005
Date registered
25/11/2005
Date last updated
11/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of acupuncture on reducing primary dysmenorrhoea: a randomised controlled trial
Scientific title
The influence of acupuncture on reducing primary dysmenorrhoea: a randomised controlled trial
Secondary ID [1] 290892 0
DAT
Universal Trial Number (UTN)
Trial acronym
DAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhoea 922 0
Condition category
Condition code
Reproductive Health and Childbirth 989 989 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture treatment. One treatment weekly for 3 weeks followed by a week of no treatment during the week of expected menses, for 3 menstrual cycles.
Intervention code [1] 726 0
Treatment: Other
Comparator / control treatment
Sham acupuncture treatment. One treatment weekly for 3 weeks followed by a week of no treatment during the week of expected menses, for 3 menstrual cycles.
Control group
Placebo

Outcomes
Primary outcome [1] 1313 0
Pain intensity measured by VAS every day of the menses
Timepoint [1] 1313 0
At 3, 6 and 12 months after trial entry
Primary outcome [2] 1314 0
Duration of pain each day of menstruation
Timepoint [2] 1314 0
At 3, 6 and 12 months after trial entry
Primary outcome [3] 1315 0
Overall improvement in dysmenorrhoea (measured by change in dysmenorrhoeic symptoms)
Timepoint [3] 1315 0
At 3, 6 and 12 months after trial entry
Secondary outcome [1] 2351 0
a. The proportion of women requiring additional analgesia or pain relief to their assigned treatment during menses.
Timepoint [1] 2351 0
At 3, 6 and 12 months after trial entry
Secondary outcome [2] 2352 0
b. Time to remedication: hours from the onset of menstruation to administration of additional analgesic.
Timepoint [2] 2352 0
At 3, 6 and 12 months after trial entry
Secondary outcome [3] 2353 0
c. The proportion of women requiring additional forms of therapy to alleviate their menstrual pain.
Timepoint [3] 2353 0
At 3, 6 and 12 months after trial entry
Secondary outcome [4] 2354 0
d. Proportion of women reporting restricted daily life activities or an absence from work or school.
Timepoint [4] 2354 0
At 3, 6 and 12 months after trial entry
Secondary outcome [5] 2355 0
e. Measure of health status using the Short Form 35 (SF36) on the second day of menstruation.
Timepoint [5] 2355 0
At 3, 6 and 12 months after trial entry

Eligibility
Key inclusion criteria
Diagnosis of primary dysmenorrhoea.
Minimum age
14 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with diagnosed secondary dysmenorrhoea (defined as identifiable pelvic pathology), or dysmenorrhoea associated with an intrauterine device, or women with mild or infrequent dysmenorrhoea.

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)
Central telephone randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2003
Actual
12/02/2003
Date of last participant enrolment
Anticipated
Actual
25/08/2005
Date of last data collection
Anticipated
Actual
30/06/2006
Sample size
Target
120
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1086 0
Government body
Name [1] 1086 0
NHMRC Project Grant 250325
Country [1] 1086 0
Australia
Primary sponsor type
Hospital
Name
Women's & Children's Hospital
Address
72 King William Rd, North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 947 0
None
Name [1] 947 0
Nil
Address [1] 947 0
Country [1] 947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2390 0
Women's and Children's Hospital
Ethics committee address [1] 2390 0
Ethics committee country [1] 2390 0
Australia
Date submitted for ethics approval [1] 2390 0
Approval date [1] 2390 0
01/05/2001
Ethics approval number [1] 2390 0

Summary
Brief summary
The medical, social and economic consequences of dysmenorrhoea are substantial and the prevalence studies emphasise dysmenorrhoea is an important women's health issue. The growing use of unproven complementary and alternative therapies by consumers highlights the need for scientifically rigorous research to identify those complementary and alternative therapies that are effective and safe.
The Cochrane systematic review and small controlled trials suggest acupuncture may have a role in alleviating dysmenorrhoea. There is clearly a need for a large, pragmatic, well designed, randomised controlled trial to determine the effectiveness of acupuncture on dysmenorrhoea.

The primary hypotheses of this study are that the use of acupuncture in women with dysmenorrhoea compared with sham acupuncture will
1. be effective at reducing their symptoms of dysmenorrhoea as measured by:
a) reduced pain and duration of pain,
b) reduced need for pain relief,
c) an overall improvement in their symptoms,

2. improve their quality of life, as measured by
a) improved quality of life indices,
b) reduced time off work or from school,
c) less restriction on daily life activities,
d) less side effects from treatment,

The secondary hypotheses of the study are the use of acupuncture in women with dysmenorrhoea compared with sham acupuncture will
1. be effective at meeting women’s expectations as measured by
a) acceptability of treatment options for the treatment of dysmenorrhoea.
Trial website
Trial related presentations / publications
Acupuncture to treat primary dysmenorrhea in women: a randomized controlled trial.
Smith CA, Crowther CA, Petrucco O, Beilby J, Dent H.
Evid Based Complement Alternat Med. 2011;2011:612464. doi: 10.1093/ecam/nep239. Epub 2011 Mar 20.
Public notes
Attachments [1] 1356 1356 0 0
/AnzctrAttachments/846-Smith CA et al Evid Based Complement Alternat Med 2011.pdf

Contacts
Principal investigator
Name 36215 0
Prof Caroline Crowther
Address 36215 0
Discipline Obstetrics & Gynaecology, University of Adelaide
Women's & Children's Hospital, 72 King William Rd, North Adelaide SA 5006
Country 36215 0
Australia
Phone 36215 0
+61 8 8161 7619
Fax 36215 0
Email 36215 0
caroline.crowther@adelaide.edu.au
Contact person for public queries
Name 9915 0
Prof Caroline Crowther
Address 9915 0
Department of Obstetrics & Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide SA 5006
Country 9915 0
Australia
Phone 9915 0
+61 8 8161 7619
Fax 9915 0
+61 8 81617652
Email 9915 0
caroline.crowther@adelaide.edu.au
Contact person for scientific queries
Name 843 0
Prof Caroline Crowther
Address 843 0
Department of Obstetrics & Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide SA 5006
Country 843 0
Australia
Phone 843 0
+61 8 8161 7619
Fax 843 0
+61 8 81617652
Email 843 0
caroline.crowther@adelaide.edu.au

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

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