ANZCTR - Registration

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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

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]

NIL

Universal Trial Number (UTN)

U1111-1191-0445

Trial acronym

ACUENDO

Linked study record

Health condition

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

Endometriosis

Chronic pelvic pain

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Renal and Urogenital

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]

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]

0-10 rated numeric rating scale (NRS) for non-cyclical pelvic pain

Timepoint [1]

Scored daily except during the menstrual period during the trial period

Primary outcome [2]

0-10 rated numeric rating scale (NRS) for menstrual related pelvic pain (dysmenorrhea)

Timepoint [2]

Daily during days with menstrual bleeding present while in the trial period.

Secondary outcome [1]

EEG - changes in default mode network

Timepoint [1]

Baseline and end of intervention

Secondary outcome [2]

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]

Baseline and end of intervention

Secondary outcome [3]

Changes in serum levels of IL-6 as measured by serum assay

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Western Sydney University

Address [1]

Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee Western Sydney University

Ethics committee address [1]

Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2016

Approval date [1]

14/12/2016

Ethics approval number [1]

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

Dr Mike Armour

Address

National Institute of Complementary Medicine
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61415363201

Fax

m.armour@westernsydney.edu.au

Contact person for public queries

Name

Mike Armour

Address

National Institute of Complementary Medicine
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61415363201

Fax

m.armour@westernsydney.edu.au

Contact person for scientific queries

Name

Mike Armour

Address

National Institute of Complementary Medicine
Western Sydney University Building 5, Campbelltown Campus Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61415363201

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
925	Study 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

Source	Title	Year of Publication	DOI
Embase	Manual 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.	2018	https://dx.doi.org/10.1186/s40814-017-0152-9
Embase	Neuronal Correlates of Cognitive Control Are Altered in Women With Endometriosis and Chronic Pelvic Pain.	2020	https://dx.doi.org/10.3389/fnsys.2020.593581
Embase	Manual Acupuncture plus Usual Care Versus Usual Care Alone in the Treatment of Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Feasibility Study.	2021	https://dx.doi.org/10.1089/acm.2021.0004
Embase	Frontocentral delta-beta amplitude coupling in endometriosis-related chronic pelvic pain.	2023	https://dx.doi.org/10.1016/j.clinph.2023.02.173

N.B. These documents automatically identified may not have been verified by the study sponsor.

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