ANZCTR - Registration

Please note that the copy function is not enabled for this field.
If you wish to modify existing outcomes, please copy and paste the current outcome text into the Update field.

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

DAT

Universal Trial Number (UTN)

Trial acronym

DAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Primary Dysmenorrhoea

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Pain intensity measured by VAS every day of the menses

Timepoint [1]

At 3, 6 and 12 months after trial entry

Primary outcome [2]

Duration of pain each day of menstruation

Timepoint [2]

At 3, 6 and 12 months after trial entry

Primary outcome [3]

Overall improvement in dysmenorrhoea (measured by change in dysmenorrhoeic symptoms)

Timepoint [3]

At 3, 6 and 12 months after trial entry

Secondary outcome [1]

a. The proportion of women requiring additional analgesia or pain relief to their assigned treatment during menses.

Timepoint [1]

At 3, 6 and 12 months after trial entry

Secondary outcome [2]

b. Time to remedication: hours from the onset of menstruation to administration of additional analgesic.

Timepoint [2]

At 3, 6 and 12 months after trial entry

Secondary outcome [3]

c. The proportion of women requiring additional forms of therapy to alleviate their menstrual pain.

Timepoint [3]

At 3, 6 and 12 months after trial entry

Secondary outcome [4]

d. Proportion of women reporting restricted daily life activities or an absence from work or school.

Timepoint [4]

At 3, 6 and 12 months after trial entry

Secondary outcome [5]

e. Measure of health status using the Short Form 35 (SF36) on the second day of menstruation.

Timepoint [5]

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]

Government body

Name [1]

NHMRC Project Grant 250325

Address [1]

GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601

Country [1]

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]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/05/2001

Ethics approval number [1]

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]

/AnzctrAttachments/846-Smith CA et al Evid Based Complement Alternat Med 2011.pdf

Contacts

Principal investigator

Name

Prof Caroline Crowther

Address

Discipline Obstetrics & Gynaecology, University of Adelaide
Women's & Children's Hospital, 72 King William Rd, North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

Email

caroline.crowther@adelaide.edu.au

Contact person for public queries

Name

Caroline Crowther

Address

Department of Obstetrics & Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

+61 8 81617652

Email

caroline.crowther@adelaide.edu.au

Contact person for scientific queries

Name

Caroline Crowther

Address

Department of Obstetrics & Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

+61 8 81617652

Email

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.