ANZCTR - Registration

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

ACTRN12613000351718

Ethics application status

Approved

Date submitted

27/03/2013

Date registered

3/04/2013

Date last updated

9/02/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Acupuncture for Primary Dysmenorrhea: Examining the role of frequency of treatment and mode of stimulation on clinical outcomes

Scientific title

In reproductive age women with primary dysmenorrhea, what is the effect of changing frequency of acupuncture treatment and mode of stimulation on menstrual pain and secondary symptoms of dysmenorrhea

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1140-2666

Trial acronym

Linked study record

Health condition

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

Primary Dysmenorrhea

Condition category

Condition code

Reproductive Health and Childbirth

Menstruation and menopause

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Manual acupuncture is provided by manual stimulation of the needle. Initial DeQi manually is obtained then manual stimulation at least once during the treatment session.
Electro acupuncture is using an ITOH ES-160 electro acupuncture machine. Initial DeQi is obtained manually then a 2/100Hz stimulation frequency is used.

Arm 1: Manual acupuncture treatment delivered for 20-30 minutes once per week starting the week after menses and then once in the first two days of the menstrual period for three menstrual cycles
Arm 2: Manual acupuncture treatment delivered for 20-30 minutes three times in the week prior to menses and then once in the first two days of the menstrual period for three menstrual cycles
Arm 3: Electro acupuncture treatment delivered for 20-30 minutes once per week starting the week after menses and then once in the first two days of the menstrual period for three menstrual cycles
Arm 4: Electro acupuncture treatment delivered for 20-30 minutes three times in the week prior to menses and then once in the first two days of the menstrual period for three menstrual cycles .

All treatments are determined based on Traditional Chinese Medicine (TCM) diagnosis. A manualised protocol is used which allows selection from a number of suitable acupuncture points based on the TCM diagnosis.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Lifestyle

Comparator / control treatment

There are 4 treatment groups being compared in this trial, as described in the 'Description of intervention' field above.

Control group

Active

Outcomes

Primary outcome [1]

Numerical rating scale (NRS) for pain. Each subject will keep a menstrual diary provided by the researcher. This will note the day of menses, average and maximum pain per day on an 11 point NRS with 0 being no pain and 10 being the worst pain imaginable. The primary endpoint is a 20% difference in NRS rated average pain severity between groups.

Timepoint [1]

Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion

Secondary outcome [1]

Duration of menstrual pain (hours) measured by the menstrual pain diary

Timepoint [1]

Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion

Secondary outcome [2]

Health Related Quality of Life as measured by the Short Form Health Survey (SF-36)

Timepoint [2]

baseline and the menstrual period post trial completion

Secondary outcome [3]

Patient satisfaction as measured by trial exit questionnaire

Timepoint [3]

Final acupuncture treatment session

Secondary outcome [4]

Menstrual characteristics (flow/clots) measured by the menstrual pain diary

Timepoint [4]

Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion

Secondary outcome [5]

Pain relief taken (type, dosage, number of doses) measured by the menstrual pain diary

Timepoint [5]

Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion

Secondary outcome [6]

non pharmacological interventions (heat,rest) measured by the menstrual pain diary

Timepoint [6]

Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion

Secondary outcome [7]

secondary symptoms of dysmenorrhea (headache, vomiting etc) measured by the menstrual pain diary

Timepoint [7]

Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion

Eligibility

Key inclusion criteria

Women with suspected or confirmed primary dysmenorrhea as defined by the following: * Age 18-45 years * History of period pain beginning before the age of 18 OR after the age of 18 with negative screening for secondary dysmenorrhea* Pain greater than or equal to 3 out of 10 on a numeric rating scale during the first three days of menses for at least two of the past 3 menstrual cycles. * Regular menstrual cycles (28 +/- 7 days) for the last three months. * Understands spoken and written English * Able to give informed consent

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

* Previous diagnosis of endometriosis or secondary dysmenorrhea.
* Abdominal Surgery in the previous 3 months
* Injectable or implant contraceptives (Depo provera, Jadelle, Murina ) within the last 3 months
* Oral Contraceptive usage started less than 3 months ago
* Chronic pain conditions ( >14 days per month with pain)
* Current mental health illness
* Neuropathic pain secondary to surgery
* Sterilisation

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 randomisation via computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation generated by SealedEnvelope.com

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Factorial

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2013

Actual

19/06/2013

Date of last participant enrolment

Anticipated

Actual

30/01/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Country [2]

New Zealand

State/province [2]

Wellington

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Western Sydney

Address [1]

James Ruse Dr Parramatta NSW 2150, Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Sydney

Address

James Ruse Dr Parramatta NSW 2150, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UWS Human Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/04/2013

Approval date [1]

15/05/2013

Ethics approval number [1]

H10082

Ethics committee name [2]

Health and Disability Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

25/03/2013

Approval date [2]

01/05/2013

Ethics approval number [2]

13/CEN/60

Summary

Brief summary

Primary Dysmenorrhea (PD) is the most common gynaecological complaint in menstruating women with over 75% of women suffering at some stage during their reproductive years. Common symptoms of PD are cramping lower abdominal pain, nausea, vomiting, headache and lower back pain. Women who suffer from regular PD are more likely to have work or school absence as well as lower quality of life and increased risk of psychological and chronic pain related disorders. Pragmatic trials of acupuncture have shown a reduction in pain and an improvement in quality of life in women with PD. However to date there has been scant evidence for how changing the 'dosage' of acupuncture would affect the outcome in women with PD. 

The primary aim of this project is to examine the affect of changing frequency and type of stimulation on the symptoms of primary dysmenorrhea. 

To achieve this a 4 group randomised controlled trial will be used. Women will be given individualised acupuncture treatments based on their group allocation; high frequency manual acupuncture, low frequency manual acupuncture, high frequency electro acupuncture and low frequency electro acupuncture. Treatment will be given for three menstrual cycles and the primary outcome is a reduction in peak menstrual pain. Participants in the trial will be invited to participate in an interview to share their experiences.

Trial website

http://www.uws.edu.au/complemed/complementary_medicine/clinical_trials/acupuncture_treatment_for_period_pain_clinical_trial

Trial related presentations / publications

Publication: In process of writing RCT publication.

Presentation: 
AACMAC July 2015, Adelaide, Australia - Acupuncture treatment for primary dysmenorrhea: The effect of changing treatment timing and mode of stimulation in a randomised trial
NZRA conference August 2015, Wellington, New Zealand - Acupuncture treatment for primary dysmenorrhea: The effect of changing treatment timing and mode of stimulation in a randomised trial

Poster:
ISAMS October 2015, Dunedin, New Zealand - Acupuncture treatment for primary dysmenorrhea: The effect of changing treatment timing and mode of stimulation in a randomised trial.

Public notes

Contacts

Principal investigator

Name

Mr Mike Armour

Address

Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+6421906644

Fax

m.armour@uws.edu.au

Contact person for public queries

Name

Mike Armour

Address

Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+6421906644

Fax

m.armour@uws.edu.au

Contact person for scientific queries

Name

Mike Armour

Address

Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+6421906644

Fax

m.armour@uws.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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically