Trial registered on ANZCTR


Trial ID
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] 282197 0
Nil
Universal Trial Number (UTN)
U1111-1140-2666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhea 288710 0
Condition category
Condition code
Reproductive Health and Childbirth 289060 289060 0 0
Menstruation and menopause
Alternative and Complementary Medicine 289078 289078 0 0
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] 286805 0
Treatment: Devices
Intervention code [2] 286806 0
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] 289173 0
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] 289173 0
Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion
Secondary outcome [1] 301963 0
Duration of menstrual pain (hours) measured by the menstrual pain diary
Timepoint [1] 301963 0
Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion
Secondary outcome [2] 301964 0
Health Related Quality of Life as measured by the Short Form Health Survey (SF-36)
Timepoint [2] 301964 0
baseline and the menstrual period post trial completion
Secondary outcome [3] 301965 0
Patient satisfaction as measured by trial exit questionnaire
Timepoint [3] 301965 0
Final acupuncture treatment session
Secondary outcome [4] 301974 0
Menstrual characteristics (flow/clots) measured by the menstrual pain diary
Timepoint [4] 301974 0
Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion
Secondary outcome [5] 301975 0
Pain relief taken (type, dosage, number of doses) measured by the menstrual pain diary
Timepoint [5] 301975 0
Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion
Secondary outcome [6] 301976 0
non pharmacological interventions (heat,rest) measured by the menstrual pain diary
Timepoint [6] 301976 0
Baseline, each menstrual period for three menstrual cycles and the menstrual period following trial completion
Secondary outcome [7] 301977 0
secondary symptoms of dysmenorrhea (headache, vomiting etc) measured by the menstrual pain diary
Timepoint [7] 301977 0
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
Gender
Females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment outside Australia
Country [1] 4957 0
New Zealand
State/province [1] 4957 0
Auckland
Country [2] 4958 0
New Zealand
State/province [2] 4958 0
Wellington

Funding & Sponsors
Funding source category [1] 286960 0
University
Name [1] 286960 0
University of Western Sydney
Address [1] 286960 0
James Ruse Dr Parramatta NSW 2150, Australia
Country [1] 286960 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
James Ruse Dr Parramatta NSW 2150, Australia
Country
Australia
Secondary sponsor category [1] 285745 0
None
Name [1] 285745 0
Address [1] 285745 0
Country [1] 285745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289009 0
UWS Human Ethics Committee
Ethics committee address [1] 289009 0
Ethics committee country [1] 289009 0
Australia
Date submitted for ethics approval [1] 289009 0
02/04/2013
Approval date [1] 289009 0
15/05/2013
Ethics approval number [1] 289009 0
H10082
Ethics committee name [2] 289010 0
Health and Disability Ethics Committee
Ethics committee address [2] 289010 0
Ethics committee country [2] 289010 0
New Zealand
Date submitted for ethics approval [2] 289010 0
25/03/2013
Approval date [2] 289010 0
01/05/2013
Ethics approval number [2] 289010 0
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 38790 0
Mr Mike Armour
Address 38790 0
Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 38790 0
Australia
Phone 38790 0
+6421906644
Fax 38790 0
Email 38790 0
m.armour@uws.edu.au
Contact person for public queries
Name 38791 0
Mr Mike Armour
Address 38791 0
Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 38791 0
Australia
Phone 38791 0
+6421906644
Fax 38791 0
Email 38791 0
m.armour@uws.edu.au
Contact person for scientific queries
Name 38792 0
Mr Mike Armour
Address 38792 0
Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 38792 0
Australia
Phone 38792 0
+6421906644
Fax 38792 0
Email 38792 0
m.armour@uws.edu.au