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Trial registered on ANZCTR


Registration number
ACTRN12609000095268
Ethics application status
Approved
Date submitted
16/01/2009
Date registered
11/02/2009
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for vasomotor symptoms in the postmenopause and menopausal transition: a randomised placebo-controlled pilot study
Scientific title
A randomised controlled pilot study of the efficacy of needle acupuncture vs placebo acupuncture in reducing vasomotor symptom severity and frequency in women during the postmenopause and menopausal transition
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasomotor symptoms during the menopausal transition and postmenopause 4209 0
Condition category
Condition code
Reproductive Health and Childbirth 4422 4422 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Needle acupuncture will be given to women randomised to the intervention group. They will receive ten sessions of acupuncture over eight weeks. Treatments will be given twice weekly for the first fortnight then weekly. Needles will be retained for 20-30 minutes and will be stimulated manually every 10 minutes. Needles will be inserted into points on ankles, elbows, wrists and abdomen. To maintain blinding, a base unit comprising a guide tube and base plate (see below - control group) will also be used in the intervention group.
Intervention code [1] 4027 0
Treatment: Other
Comparator / control treatment
Placebo acupuncture will be administered using the "Park Sham device", which consists of a blunt needle and a base unit comprising a guide tube and base plate, which is attached to the skin with adhesives. This form of acupuncture is also referred to as "non invasive sham". Placebo acupuncture will be given over 10 sessions over 8 weeks. Treatments will be twice weekly for the fist fortnight then weekly. Placebo needles will be placed over points on the ankles, wrists, elbows, and abdomen. Needles will be retained for 20-30 minutes and will be stimulated manually every 10 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 5305 0
Vasomotor symptom score, comprising vasomotor symptom severity and frequency, as measured using a 7 day hot flush diary
Timepoint [1] 5305 0
baseline, 4 weeks, 6 weeks, 8 weeks; followed by short term followup at 3 months post end of treatment
Secondary outcome [1] 8927 0
Quality of life, as measured by the Menopause - Specific Quality of LIfe Interventions questionnaire (MENQOL)
Timepoint [1] 8927 0
baseline, 4 weeks, 6 weeks, 8 weeks; followed by short term followup at 3 months post end of treatment

Eligibility
Key inclusion criteria
Women who are having an average of 7 hot flushes or more a day over a week; and whose Traditional Chinese Medicine (TCM) diagnosis is predominantly Kidney Yin Deficiency, as assessed by a Chinese medicine questionnaire and a history and examination
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. younger than 40yo (therefore diagnosed as having Premature Ovarian Failure),
2. any medical reason to be amenorrheic (Pregnancy, hyperprolactinemia, Cushing’s syndrome etc),
3. poorly controlled hyper or hypothyroidism,
4. menopausal as a result of surgery,
5. breast cancer or suffering hot flushes as a result of aromatase inhibitor therapy,
6. have commenced using any pharmacological or complementary therapy for hot flushes in the past eight weeks,
7. unable to read or write sufficiently in English to complete hot flush diaries and Menopause - Specific Quality of Life (MENQOL) questionnaires (the questionnaire requires a Grade 6 reading level)[19],
8. any needle acupuncture treatment in the past,
9. relative contraindications to acupuncture (use of anticoagulant drugs, heart valve disease, poorly controlled diabetes mellitus),
10. unwilling or unable to attend for acupuncture/placebo acupuncture for 8 weeks
11. unable to give informed consent

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)
Women will be assigned to their treatment group by the chief investigator selecting the next consecutive sealed opaque envelope upon enrolling them into the trial. These envelopes are prepared by a research assistant and are numbered 1-26 (there are 26 participants in this pilot study). The envelopes contain either placebo or true acupuncture needles in their blister pack, which indicate to the chief investigator (who will be providing the acupuncture treatments) which treatment group the woman has been allocated to. Prior to the envelopes being opened, the woman's name and ID Number will be written on the envelope together with the date of randomisation, which will avoid any contamination of the randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician will create a computer-generated randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4389 0
Government body
Name [1] 4389 0
Royal Australian College of General Practitioners (RACGP)
Country [1] 4389 0
Australia
Funding source category [2] 4390 0
Government body
Name [2] 4390 0
General Practice Education and Training
Country [2] 4390 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
200 Berkeley St
Carlton Victoria 3053
Country
Australia
Secondary sponsor category [1] 4035 0
None
Name [1] 4035 0
Address [1] 4035 0
Country [1] 4035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6437 0
Human Research Ethics Committee, University of Melbourne
Ethics committee address [1] 6437 0
Ethics committee country [1] 6437 0
Australia
Date submitted for ethics approval [1] 6437 0
Approval date [1] 6437 0
28/10/2009
Ethics approval number [1] 6437 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35097 0
Address 35097 0
Country 35097 0
Phone 35097 0
Fax 35097 0
Email 35097 0
Contact person for public queries
Name 12444 0
Carolyn Ee
Address 12444 0
200 Berkeley St
Carlton Victoria
3053
Country 12444 0
Australia
Phone 12444 0
+61 3 95445993
Fax 12444 0
Email 12444 0
ccee@unimelb.edu.au
Contact person for scientific queries
Name 3372 0
Carolyn Ee
Address 3372 0
200 Berkeley St
Carlton Victoria
3053
Country 3372 0
Australia
Phone 3372 0
+61 3 95445993
Fax 3372 0
Email 3372 0
ccee@unimelb.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.