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Trial registered on ANZCTR


Registration number
ACTRN12618000975291
Ethics application status
Approved
Date submitted
29/05/2018
Date registered
8/06/2018
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture or ear acupuncture for weight loss in Polycystic Ovary Syndrome
Scientific title
Acupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: a randomised controlled feasibility study
Secondary ID [1] 295010 0
Nil
Universal Trial Number (UTN)
U1111-1214-7552
Trial acronym
AcuPCOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 308029 0
Overweight 308030 0
Obesity 308112 0
Condition category
Condition code
Metabolic and Endocrine 307068 307068 0 0
Metabolic disorders
Alternative and Complementary Medicine 307069 307069 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 307152 307152 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In both interventions, case report forms will be completed at each treatment to assess adherence.

Arm 1: Body acupuncture and lifestyle

The intervention in this arm is Chinese medicine needle acupuncture delivered in a semi-pragmatic setting (as per usual clinical practice but treating acupuncturists must include acupuncture points from a list provided).
Individualisation of treatment
Acupuncturists are to perform Chinese medicine diagnosis based on history and examination as per usual clinical practice. The list of points that acupuncturists must select from are based on acupuncture points used in other clinical trials on acupuncture for weight loss in PCOS and also on a textbook and literature review.

Extent to which treatment will be varied
In choosing the acupuncture prescription, treating acupuncturists are given the following instructions:
• Treatment of obesity/overweight is the primary objective of the acupuncture treatment
• At least six acupuncture points must be chosen from a list of 17 core acupuncture points that will be provided to the practitioner. These points are chosen from the traditional points that are recommended for treatment of syndromes that are related to obesity and PCOS, and from the points used in previous acupuncture for obesity and PCOS trials.
• Points on the chest or back must be avoided to avoid risk of pneumothorax.
• De qi must be obtained for each point using thrusting, twirling and rotating, until the participant reports numbness, heaviness, pressure, soreness or tingling.
• Needles are manipulated after ten minutes (thrusting, twirling and rotating until De qi is reported)
• Needles are withdrawn after 30 minutes

Details of needling
A minimum of ten acupuncture needles will be inserted per session.
The core acupuncture points to be used are ST36, SP6, ST25, ST40, CV12, CV6, LI11, SP9, CV9, CV3, CV4, LI4, KI13, KI7, ST28, LR3, GB34. These points are located on the upper or lower limbs or abdomen. Acupuncture points will be generally needled bilaterally, unless they are midline points, or there are other reasons for unilateral needling for example pain or bruising on one side.
Needles will be inserted until de qi is obtained. De qi is defined as numbness, heaviness, pressure, soreness or tingling.
A combination of manual and electrical stimulation (electro-acupuncture) will be used. De qi must be obtained for each point using thrusting, twirling and rotating, until the participant reports numbness, heaviness, pressure, soreness or tingling. Electro-acupuncture will be applied to four acupuncture points. Electro-acupuncture is delivered using TGA-approved electro-acupuncture devices that deliver low-frequency electrical pulses to the attached needles. Electroacupuncture will be given to ST28 - SP6 bilaterally, at 0.3ms pulse width, 2Hz, and at a stimulation level that causes a mild muscle contraction but without pain or discomfort.
Needles are retained for 30 minutes.
Needles are stainless steel, sterile and disposable. Acupuncture needles are standard , 32G thickness and 30mm length.
Women allocated to the acupuncture group will receive a total of 11 treatments of acupuncture over 12 weeks (twice a week for the first two weeks, weekly for four weeks, then fortnightly for 3 treatments). This tapering schedule is consistent with usual clinical practice. Needles are retained for 30 minutes.

Other components of treatment
Treating acupuncturists may provide diet and lifestyle advice according to Chinese medicine principles. This advice usually consists of advice to avoid ingesting foods that are considered too “hot” or “cold” for the patient’s constitution. However, no additional Chinese medicine treatments will be provided including Chinese herbal medicine, or additional physical or stimulation treatments such as moxibustion or cupping.

Participants will attend for treatment at private clinics of the treating acupuncturists. Treating acupuncturists are advised that they may proceed according to usual clinical practice with the following limitations:
• The acupuncture protocol must be targeted at weight loss as the primary outcome
• The acupuncture protocol must adhere to the standardization applied to acupuncture points, manipulation, stimulation, retention time, frequency as described above
• Only body acupuncture, diet and lifestyle advice (according to Chinese medicine) may be provided.
Practitioners are free to practise as they usually practise. They will be trained to ask about adverse events, and to treat patients warmly and courteously. All efforts will be made to ensure the participants have a comfortable acupuncture experience.
Practitioners will record details of each treatment on an individual Case Report Form which will be kept in a locked cupboard in the clinic and returned to the research team at the end of the study.
Practitioner background
A minimum of six practitioners have been chosen to administer the treatments. They are have a Bachelor degree in Chinese Medicine, have five or more years of clinical experience and are registered with the Chinese Medicine Registration Board.


Co-intervention: Lifestyle intervention (health coaching) as provided by GethealthyNSW. All participants will register for the GetHealthy NSW program. All women will receive individually-tailored telephone-based lifestyle coaching for 3 months, consisting of 6 telephone calls from an exercise physiologist with nutrition training, exploring healthy eating, physical activity, and weight management. Lifestyle coaching is provided by Healthways under the GethealthyNSW program, which has been offered to all NSW residents for free by the NSW government since 2009. Medical referral is not required. Information given to participants is consistent with national guidelines on physical activity and nutrition, which are also recommended by national PCOS guidelines.

Arm 2: Auricular Electro-acupuncture and lifestyle

The intervention in this arm is auricular electro-acupuncture using a fixed protocol that is informed by both Chinese medical and medical acupuncture principles.
Reasoning for treatment provided
No Chinese medicine diagnosis is required. The acupuncture points are chosen based on a literature review and expert consensus on the traditional and physiological indications of the points.
Extent to which treatment will be varied
There is to be no variation in treatment.
Details of needling
Each subject will receive needling at three acupuncture points on the concha of one ear only. The ears are to be alternated between visits unless there is any objection from the participant.
The core acupuncture points on the concha of the ear to be used are the Stomach, Appetite Control, and Thalamus points.
No de qi sensation is to be sought. Needles are to be inserted superficially and not into the cartilage of the ear.
The Neurova device will be attached after insertion of the needles to the ear, according to the manufacturer's instructions.
Needles are retained for up to 96 hours. The participant is to remove the Neurova device by gently pulling out the needles and disconnecting the wire. The needles are then placed into a provided sharps container. Gentle pressure is applied with a cotton ball if there is any bleeding. Participants can remove the device before 96 hours if they experience significant discomfort. Participants bring the sharps container back to the post-intervention visit for adequate biological hazard waste disposal through NICM laboratories.
Needles are surgical grade titanium, sterile and disposable and approximately 6mm in length.
Women allocated to the AEA group will receive a total of 6 treatments of acupuncture over 12 weeks (twice a week for the first two weeks, then fortnightly for four treatments).

Other components of treatment
No additional Chinese medicine treatments will be provided including body acupuncture, Chinese herbal medicine, or additional physical or stimulation treatments such as moxibustion or cupping.
Practitioner background
A minimum of six practitioners have been chosen to administer the treatments. They are have a Bachelor degree in Chinese Medicine, have five or more years of clinical experience and are registered with the Chinese Medicine Registration Board.

Participants in this arm will also receive the co-intervention of telephone-based health coaching/lifestyle intervention as described in the comparator

Intervention code [1] 301345 0
Other interventions
Comparator / control treatment
Arm 3: Lifestyle intervention (health coaching) alone

In this arm the control is Lifestyle intervention (health coaching) as provided by GethealthyNSW
women will receive individually-tailored telephone-based lifestyle coaching for 3 months, consisting of up to 13 telephone calls from an exercise physiologist with nutrition training, exploring healthy eating, physical activity, and weight management. Lifestyle coaching is provided by Healthways under the GethealthyNSW program, which has been offered to all NSW residents for free by the NSW government since 2009. Medical referral is not required. Information given to participants is consistent with national guidelines on physical activity and nutrition, which are also recommended by national PCOS guidelines.
Control group
Active

Outcomes
Primary outcome [1] 306040 0
Recruitment rates calculated as : number of women enrolled per month of active recruitment, number of enquiries per month of active recruitment; percentage conversion to enrolment measured as n enrolled/n enquiries and n enrolled/n potentially eligible.
Timepoint [1] 306040 0
3 months post-intervention commencement
Primary outcome [2] 306041 0
Acceptability assessed by an exit survey designed specifically for the study
Timepoint [2] 306041 0
3 months post-intervention commencement
Primary outcome [3] 306117 0
Retention rate calculated as number of women remaining in study at 3 months post intervention as a proportion of number of women who enrolled in the study
Timepoint [3] 306117 0
3 months post-intervention commencement
Secondary outcome [1] 347399 0
Weight using digital scale
Timepoint [1] 347399 0
Baseline and 3 months post intervention commencement
Secondary outcome [2] 347400 0
Blood pressure by digital blood pressure monitor
Timepoint [2] 347400 0
Baseline and 3 months post intervention commencement
Secondary outcome [3] 347404 0
Heart rate variability measured only by ECG monitor
Timepoint [3] 347404 0
Baseline and 3 months post intervention
Secondary outcome [4] 347405 0
Health related Quality of Life (MPCOS Q)
Timepoint [4] 347405 0
Baseline and 3 months post intervention commencement
Secondary outcome [5] 347406 0
Anxiety and Depression (DASS 21)
Timepoint [5] 347406 0
Baseline and 3 months post intervention commencement
Secondary outcome [6] 347407 0
Weight Efficacy Lifestyle Questionnaire
Timepoint [6] 347407 0
Baseline and 3 months post intervention commencement
Secondary outcome [7] 347408 0
modified version of the validated Multidimensional Health Locus of Control Scales
Timepoint [7] 347408 0
Baseline and 3 months post intervention commencement
Secondary outcome [8] 347409 0
Menstrual cyclicity using a participant menstrual journal recording first day of each menstrual period
Timepoint [8] 347409 0
Baseline and 3 months post intervention commencement
Secondary outcome [9] 347410 0
Clinical hirsutism score (Ferriman-Galwey)
Timepoint [9] 347410 0
Baseline and 3 months post intervention commencement
Secondary outcome [10] 347411 0
Insulin resistance (2 hr Oral Glucose Tolerance Test)
Timepoint [10] 347411 0
Baseline and 3 months post intervention commencement
Secondary outcome [11] 347412 0
Testosterone by serum assay
Timepoint [11] 347412 0
Baseline and 3 months post intervention commencement
Secondary outcome [12] 347413 0
Physical activity levels (using an accelerometer)
Timepoint [12] 347413 0
Daily for 3 months
Secondary outcome [13] 347414 0
Compliance with lifestyle coaching provided by GetHealthyNSW from brief patient survey designed specifically for the study
Timepoint [13] 347414 0
3 months post intervention commencement
Secondary outcome [14] 347415 0
Credibility and expectations of treatment using Credibility and Expectancy Questionnaire (validated, composite outcome)
Timepoint [14] 347415 0
Immediately after first treatment
Secondary outcome [15] 347613 0
Body Mass Index using digital scale and stadiometer
Timepoint [15] 347613 0
Baseline and 3 months post intervention commencement
Secondary outcome [16] 347614 0
Waist measurement by tape measure, collected during clinic visits by research assistant
Timepoint [16] 347614 0
Baseline and 3 months post intervention commencement
Secondary outcome [17] 347615 0
Glucose tolerance using 2 hr OGTT
Timepoint [17] 347615 0
Baseline and 3 months post intervention commencement
Secondary outcome [18] 347616 0
Quality of Life (EQ5D)
Timepoint [18] 347616 0
Baseline and 3 months post intervention commencement
Secondary outcome [19] 374608 0
Primary outcome: Adherence rate measured as n completing 12 week intervention and outcome measures/n enrolled
Timepoint [19] 374608 0
3 months post-baseline
Secondary outcome [20] 374609 0
Adeherence rate: n completing at least 8 of 11 acupuncture and 4 of 6 AEA treatments
Timepoint [20] 374609 0
3 months post baseline
Secondary outcome [21] 374610 0
Primary outcome: Adherence rate: n of hrs of wear of the Neurova device from case report forms completed by acupuncturists, and percentage of women who wore the device for the prescribed 96 hr duration from case report forms completed by acupuncturists
Timepoint [21] 374610 0
Post treatment
Secondary outcome [22] 374611 0
Primary Outcome: adherence rate: n completing all recommended phone calls with lifestyle intervention
Timepoint [22] 374611 0
3 months post-baseline
Secondary outcome [23] 374612 0
Primary outcome: Adverse events as collected by an Adverse Events form . Known possible adverse events include pain, bleeding, bruising, fainting
Timepoint [23] 374612 0
at each acupuncture treatment, or as needed

Eligibility
Key inclusion criteria
women aged 18-45 years
• physician diagnosis of PCOS according to the 2003 Rotterdam Criteria in previous 5 years
• BMI greater than 25 kg/m2; no other endocrine disorders;
• not pregnant/no pregnancies in preceding 6 weeks and more than 6 weeks postpartum;
• no breastfeeding within the last 6 weeks;
not on the following medications in the 3 months preceding enrolment: metformin or other medications affecting insulin and glucose metabolism, hormonal treatments for PCOS/ART including gonadotrophins and the Oral Contraceptive Pill, pharmaceutical or complementary therapies for weight loss
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Planning to conceive within the next 3 months
• Needle acupuncture in the previous 3 weeks
• Unable to provide informed consent.
• BMI >40
• anticoagulant use
• pacemaker use
• immunocompromise
• valvular heart disease

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 randomised in a 1:1 ratio to receive either acupuncture + lifestyle, AEA + lifestyle, or lifestyle alone, stratified according to BMI (BMI>25 and <30; and BMI>30). Randomisation will be performed in permuted blocks of six.
Allocation concealment
Acupuncturists will ring a central telephone number for treatment allocation once the participant has been enrolled in the study.
Implementation
Once the participant has had eligibility confirmed and has provided written informed consent, she is enrolled and given the next consecutive randomisation ID number according to BMI strata. The research assistant will inform the treating acupuncturist of the new enrolment and book the participant’s first appointment. The treating acupuncturist will ring a central telephone number for treatment allocation. The telephone service will note down the date and time of call.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created using a computer program by a researcher external to the research team. This researcher will hold the randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Recruitment, retention and adherence rates are presented with descriptive statistics. Mixed model ANOVAs will be used to determine within-group differences for continuous outcomes between baseline and 3 months, and ANCOVAs for between-group differences for continuous outcomes with baseline score as a co-variate. Intention-to-treat analysis will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22825 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 299594 0
Government body
Name [1] 299594 0
NHMRC Centre for Research Excellence in PCOS
Address [1] 299594 0
Level 1, 43-51 Kanooka Grove, Clayton, Victoria 3168
Country [1] 299594 0
Australia
Funding source category [2] 299619 0
Commercial sector/Industry
Name [2] 299619 0
Neural Ear Stimulation International
Address [2] 299619 0
20 Betz Lane
Hampton
Virginia
23666
Country [2] 299619 0
United States of America
Funding source category [3] 299620 0
University
Name [3] 299620 0
NICM Health Research Institute, Western Sydney University
Address [3] 299620 0
locked Bag 1797
Penrith NSW 2751
Country [3] 299620 0
Australia
Primary sponsor type
University
Name
NICM Health Research Institute, Western Sydney University
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 298940 0
None
Name [1] 298940 0
None
Address [1] 298940 0
NA
Country [1] 298940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300494 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 300494 0
Locked Bag 1797
Penrith 2751
NSW
Ethics committee country [1] 300494 0
Australia
Date submitted for ethics approval [1] 300494 0
Approval date [1] 300494 0
30/04/2018
Ethics approval number [1] 300494 0

Summary
Brief summary
This is a preliminary study which will provide information on whether it is possible to conduct a larger clinical trial on acupuncture or ear acupuncture for weight loss in Polycystic Ovary Syndrome (PCOS). We are recruiting adult women with PCOS aged up to 45 years old who have a BMI of over 25. All women will receive 3 months of telephone-based health coaching. Women will be randomly allocated to receive either health coaching alone; acupuncture and health coaching; or ear acupuncture and health coaching. The aim of this study is to see if acupuncture may be effective, whether it is possible (feasible) to conduct a larger study, and whether our proposed treatment is acceptable to women in the community with PCOS. We will be collecting data on weight, insulin and glucose tolerance, testosterone levels, and other symptoms and signs of PCOS as well as measuring heart rate variability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83842 0
Dr Carolyn Ee
Address 83842 0
NICM Health Research Institute, Western Sydney University
Locked Bag 1797
Penrith 2751
NSW
Country 83842 0
Australia
Phone 83842 0
+61413319830
Fax 83842 0
Email 83842 0
c.ee@westernsydney.edu.au
Contact person for public queries
Name 83843 0
Dr Carolyn Ee
Address 83843 0
NICM Health Research Institute, Western Sydney University
Locked Bag 1797
Penrith 2751
NSW
Country 83843 0
Australia
Phone 83843 0
+61413319830
Fax 83843 0
Email 83843 0
c.ee@westernsydney.edu.au
Contact person for scientific queries
Name 83844 0
Dr Carolyn Ee
Address 83844 0
NICM Health Research Institute, Western Sydney University
Locked Bag 1797
Penrith 2751
NSW
Country 83844 0
Australia
Phone 83844 0
+61413319830
Fax 83844 0
Email 83844 0
c.ee@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results