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Trial registered on ANZCTR


Registration number
ACTRN12617000053325
Ethics application status
Approved
Date submitted
6/01/2017
Date registered
11/01/2017
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for the treatment of endometriosis related chronic pelvic pain
Scientific title
Acupuncture for the treatment of endometriosis related chronic pelvic pain: A feasibility study
Secondary ID [1] 290784 0
NIL
Universal Trial Number (UTN)
U1111-1191-0445
Trial acronym
ACUENDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 301409 0
Chronic pelvic pain 301410 0
Condition category
Condition code
Alternative and Complementary Medicine 301142 301142 0 0
Other alternative and complementary medicine
Renal and Urogenital 301144 301144 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual traditional Chinese medicine (TCM) style acupuncture + usual care:

TCM style acupuncture at fixed acupuncture points will be delivered twice per week for 8 weeks, 16 sessions in total.

Treatments will be delivered in Sydney, in private acupuncture practice clinics and at NICM on Western Sydney Universities Campbelltown Campus. Treatment sessions cannot be less than 48 hours apart and no more than 6 days apart. Acupuncture points will be needled bilaterally and needles retained for 25-30 minutes. Sessions will last a total of 45 minutes. Point location and needling depth will be as specified in A Manual of Acupuncture. Single use, stainless steel needles of varying gauge (.20 x 30mm or .25 x 40mm), dependent on body shape, will be used.
Acupuncture points used will include Spleen 6, Spleen 8, Spleen 10, Stomach 29, Stomach 36, Ren 3, Ren 4 and Liver 3. No other TCM interventions (such as moxibustion, or cupping therapy) will be permitted during the treatment.

All study acupuncturists will be experienced, with a minimum of a Bachelors level qualification in Acupuncture and will hold current Chinese Medicine practitioner registration with AHPRA. Practitioners will be observed at least once during the treatment period to ensure protocol compliance. Treatment session attendance will be recorded in case report forms.

Usual care consists of the current treatment as advised by the participants medical practitioner. It varies from person to person but usually includes either analgesic medication (such as non-steroidal anti-inflammatories) or hormonal treatments such as the oral contraceptive pill. Subjects will continue with all prescribed medication and can use analgesics as needed for pain relief.
Intervention code [1] 296695 0
Treatment: Other
Comparator / control treatment
Usual care only:

Usual care consists of the current treatment as advised by the participants medical practitioner. It varies from person to person but usually includes either analgesic medication (such as non-steroidal anti-inflammatories) or hormonal treatments such as the oral contraceptive pill.

Subjects will continue with all prescribed medication and can use analgesics as needed for pain relief.
Control group
Active

Outcomes
Primary outcome [1] 300547 0
0-10 rated numeric rating scale (NRS) for non-cyclical pelvic pain
Timepoint [1] 300547 0
Scored daily except during the menstrual period during the trial period
Primary outcome [2] 300548 0
0-10 rated numeric rating scale (NRS) for menstrual related pelvic pain (dysmenorrhea)
Timepoint [2] 300548 0
Daily during days with menstrual bleeding present while in the trial period.
Secondary outcome [1] 330283 0
EEG - changes in default mode network
Timepoint [1] 330283 0
Baseline and end of intervention
Secondary outcome [2] 330284 0
Pain inhibition assessed by using Conditioned Pain Modulation (CPM) testing via pressure pain threshold measurement as the test stimulation and heat pain (1 degree centigrade above tolerance) as the conditioned stimulation.
Timepoint [2] 330284 0
Baseline and end of intervention
Secondary outcome [3] 330540 0
Changes in serum levels of IL-6 as measured by serum assay
Timepoint [3] 330540 0
Baseline and end of intervention

Eligibility
Key inclusion criteria
* Women aged 18-45
* have a laparoscopic diagnosis of endometriosis in the last 5 years
* having regular menstruation
* the presence of at least one of the following: dysmenorrhea, dyspareunia, dyschezia or dysuria rated >= 4/10 on a numeric rating scale.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* endometriosis surgery within the past 6 months,
* started oral or injectable contraceptive pill, GnRH-a or danazol within the last 6 months.

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)
All investigators will be blinded to treatment allocation until data analysis is complete, although the treating acupuncturists will not be blinded. Allocation will be concealed with the use of a centralised telephone service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher external to the research team will create a computer-generated randomisation schedule. Women will be randomised on a 1:1 ratio to receive either acupuncture or usual care.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is no sample size calculation undertaken for this study due to its nature as a feasibility study. A previous feasibility study on acupuncture has shown that a sample size of 30 is sufficient to provide data on feasibility outcomes.

Baseline demographics will be reported using descriptive statistics along with recruitment rates and other feasibility data. NRS levels for pain and CPM will be analysed using a mixed model ANCOVA. Changes in IL-6 levels will be assessed using a paired t-test. Categorical data such as expectation will be analysed using Fishers exact.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2017
Actual
14/02/2017
Date of last participant enrolment
Anticipated
Actual
4/10/2017
Date of last data collection
Anticipated
1/06/2018
Actual
5/02/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295202 0
University
Name [1] 295202 0
Western Sydney University
Country [1] 295202 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 294035 0
None
Name [1] 294035 0
Address [1] 294035 0
Country [1] 294035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296554 0
Human Research Ethics Committee Western Sydney University
Ethics committee address [1] 296554 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 296554 0
Australia
Date submitted for ethics approval [1] 296554 0
30/11/2016
Approval date [1] 296554 0
14/12/2016
Ethics approval number [1] 296554 0
H11984

Summary
Brief summary
Chronic pelvic pain (CPP) is pain in the pelvis of greater than 6 months duration, and is severe enough to cause functional disability or require medical intervention. Endometriosis, the presence of endometrial tissue outside the uterus, is a common cause of CPP. Worldwide, endometriosis is as common as lower back pain. Endometriosis related CPP includes a variety of pain symptoms including dysmenorrhea (period pain), dyspareunia (pain during sexual intercourse), dyschezia (pain on bowel motions) and dysuria (pain on urination). Current treatments tend to be expensive, invasive or have significant side effects. Acupuncture shows promise in treating endometriosis related chronic pelvic pain however no studies have examined the feasibility of undertaking a fully powered trial in Australia or the effect of acupuncture on a number of objective biomarkers that are altered in women with endometriosis, such as IL-6, an inflammatory marker, or changes in functional connectivity in the brain. The aim of this study is to assess the feasibility and acceptability of acupuncture and to investigate any changes in neurological or biomarkers when using acupuncture to treat endometriosis-related chronic pelvic pain.We are partnering with Endometriosis Australia, a leading not-for-profit in Australia, to recruit women for this study. We will recruit 30 women to either acupuncture plus usual care or usual care alone. We will measure daily pain ratings as well as pain measured during the period and will take blood samples before and at the end of treatment to determine any changes in levels of IL-6. Women will also have an EEG taken to determine if there is any change in the way their brains are processing pain. This data will help provide the important information necessary to help design a larger trial to test if acupuncture is an effective adjunct to current treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71274 0
Dr Mike Armour
Address 71274 0
National Institute of Complementary Medicine
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751
Country 71274 0
Australia
Phone 71274 0
+61415363201
Fax 71274 0
Email 71274 0
m.armour@westernsydney.edu.au
Contact person for public queries
Name 71275 0
Dr Mike Armour
Address 71275 0
National Institute of Complementary Medicine
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751
Country 71275 0
Australia
Phone 71275 0
+61415363201
Fax 71275 0
Email 71275 0
m.armour@westernsydney.edu.au
Contact person for scientific queries
Name 71276 0
Dr Mike Armour
Address 71276 0
National Institute of Complementary Medicine
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751
Country 71276 0
Australia
Phone 71276 0
+61415363201
Fax 71276 0
Email 71276 0
m.armour@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual, de-identified data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
To researchers at academic institutions upon approval of methodological analysis plan
Available for what types of analyses?
IPD meta-analysis.
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
925Study protocol    https://pilotfeasibilitystudies.biomedcentral.com/... [More Details]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNeuronal Correlates of Cognitive Control Are Altered in Women With Endometriosis and Chronic Pelvic Pain.2020https://dx.doi.org/10.3389/fnsys.2020.593581
EmbaseFrontocentral delta-beta amplitude coupling in endometriosis-related chronic pelvic pain.2023https://dx.doi.org/10.1016/j.clinph.2023.02.173
EmbaseManual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: Study protocol for a randomised controlled feasibility study.2018https://dx.doi.org/10.1186/s40814-017-0152-9
EmbaseManual Acupuncture plus Usual Care Versus Usual Care Alone in the Treatment of Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Feasibility Study.2021https://dx.doi.org/10.1089/acm.2021.0004
N.B. These documents automatically identified may not have been verified by the study sponsor.