Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000988459
Ethics application status
Approved
Date submitted
21/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Traditional Chinese Medicine style acupuncture for the treatment of endometriosis: a randomized controlled trial
Scientific title
The efficacy and safety of acupuncture for pelvic pain and related symptoms in adults with endometriosis: a randomized controlled trial
Secondary ID [1] 315169 0
Nil known
Universal Trial Number (UTN)
U1111-1327-2081
Trial acronym
The EndoAcu Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 338605 0
Pelvic pain 338719 0
Condition category
Condition code
Alternative and Complementary Medicine 334905 334905 0 0
Other alternative and complementary medicine
Metabolic and Endocrine 334906 334906 0 0
Other endocrine disorders
Reproductive Health and Childbirth 334907 334907 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Verum acupuncture
Endometriosis is a chronic gynecological condition often associated with pain, and acupuncture has been investigated as a potential management option, though current evidence is limited.

Participants in the verum acupuncture group will attend ~45-minute sessions once a week for 12 weeks, during which sterile, single-use acupuncture needles will be inserted into acupuncture points according to traditional Chinese medicine principles. Needles will be retained for approximately 30 minutes per session.
Stainless steel acupuncture needles (Seirin J-Type acupuncture needles) of varying gauge (0.20 x 30mm and 0.25 x 30mm), dependent on body shape, will be used. Acupuncture needles will be provided by Acuneeds (https://www.acuneeds.com/), an online distributor for acupuncture supply where acupuncture needles can be purchased.
The verum acupuncture will follow a treatment manual developed using co-design by the research team. This treatment manual provides information on point selection according to Traditional Chinese medicine pattern differentiation and stimulation intensity according to acupuncture point.
Treatments will be provided face-to-face at NICM Health Research Institute by the PhD candidate Nora Giese. Nora Giese is trained in acupuncture and holds a Master’s Degree in Advanced Oriental Medicine (United Kingdom). She has >10 years of experience in treating people with endometriosis, with at least 15 patients with endometriosis per week.
Point location and needling depth will be as specified in A Manual of Acupuncture. No other TCM co-interventions (moxibustion, cupping, or herbal medicine) will be allowed during the trial.
Adherence will be assessed through case report forms maintained by Nora Giese, documenting the number of sessions attended, duration of each session, and any missed or incomplete treatments.
Intervention code [1] 331786 0
Treatment: Devices
Intervention code [2] 331873 0
Treatment: Other
Comparator / control treatment
Arm 2: Control acupuncture
Participants will receive the control treatment used in a previous study, which involves the superficial insertion of needles to a depth of <5 mm into each shoulder and upper arm without any stimulation.
This intervention will be communicated as a second type of acupuncture, which superficial needling technically is, as the needles are inserted into the body. As such, the same expectations can be maintained for the verum acupuncture group and the group receiving the superficial needling, which is vital to manage expectation bias.

Single use, stainless steel acupuncture needles (Seirin J-Type acupuncture needles, 0.16 x 15mm) will be used, provided by Acuneeds.
A total of 12 control acupuncture treatments once per week will be administered. Treatments will be provided face-to-face at NICM Health Research Institute by the PhD candidate Nora Giese.
Needle retention time will be 25-30 minutes. No other TCM co-interventions (moxibustion, cupping, or herbal medicine) will be allowed during the trial.
Control group
Active

Outcomes
Primary outcome [1] 342532 0
Change in overall pelvic pain severity
Timepoint [1] 342532 0
Baseline and end of treatment (week 12)
Secondary outcome [1] 451187 0
Change in overall pelvic pain severity
Timepoint [1] 451187 0
At follow-up (week 24)
Secondary outcome [2] 451189 0
Change in menstrual pain severity
Timepoint [2] 451189 0
Baseline, end of treatment (week 12) and at follow-up (week 24)
Secondary outcome [3] 451190 0
Change in non-menstrual pelvic pain severity
Timepoint [3] 451190 0
Baseline, end of treatment (week 12) and at follow-up (week 24)
Secondary outcome [4] 451191 0
Adverse events (AE)
Timepoint [4] 451191 0
End of treatment (Week 12)
Secondary outcome [5] 451192 0
Changes in number of analgesics
Timepoint [5] 451192 0
End of treatment (week 12) and at follow-up (week 24)
Secondary outcome [6] 451193 0
Change in Health Related Quality of Life (HRQoL)
Timepoint [6] 451193 0
Baseline, end of treatment (week 12) and at follow-up (week 24)
Secondary outcome [7] 451194 0
Change in most impactful symptom
Timepoint [7] 451194 0
Baseline, end of treatment (week 12) and at follow-up (week 24)
Secondary outcome [8] 451195 0
Change in pelvic pain impact
Timepoint [8] 451195 0
Baseline and end of treatment (week 12)
Secondary outcome [9] 451196 0
Overall response rate
Timepoint [9] 451196 0
End of treatment (week 12)
Secondary outcome [10] 451197 0
Change in severity and/or impact of fatigue severity
Timepoint [10] 451197 0
Baseline, end of treatment (week 12) and at follow-up (week 24)
Secondary outcome [11] 451198 0
Participant’s global impression of change
Timepoint [11] 451198 0
End of treatment (week 12)
Secondary outcome [12] 451199 0
Cost-effectiveness evaluation
Timepoint [12] 451199 0
Baseline and end of treatment (week 12)
Secondary outcome [13] 451202 0
Change in employment productivity
Timepoint [13] 451202 0
Baseline and end of treatment (week 12)
Secondary outcome [14] 451203 0
Satisfaction with the intervention
Timepoint [14] 451203 0
End of treatment (week 12)
Secondary outcome [15] 451207 0
Change in inflammatory markers
Timepoint [15] 451207 0
Baseline and end of treatment (week 12)

Eligibility
Key inclusion criteria
• Adults of reproductive age (18-45 years)
• Confirmation of endometriosis via laparoscopy, laparotomy with or without histological confirmation, specialized transvaginal ultrasound scans (TVUSS), or ovarian endometrioma detected by imaging (MRI, ultrasound) in the past five years
• Pelvic pain significant enough to seek medical attention
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Endometriosis-related surgery in the last three months
• Acupuncture treatments within the last three months
• No changes in daily endometriosis-specific medication, such as hormonal treatment within the last three months; pro re nata analgesics used for pain are exempted from this criterion.
• Phobia of needles.
• Intend to become pregnant within the next seven 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)
Randomization via REDCap will occur after consent and enrollment are confirmed. REDCap will be used to conceal allocation prior to randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block of 6 randomization sequence with an even distribution of group allocation (1:1) will be performed by NICMs Clinical Trial Manager who is external to this study. Randomization numbers will be allocated in permuted blocks of 6 randomization numbers containing 3 verum acupuncture and 3 control acupuncture randomization numbers. NICMs Clinical Trial Manager will allocate each randomization number in order of number sequence starting with the lowest number in each block and using all numbers in a block of 6 before starting with the lowest number in the next block of numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
The total sample size is 72 participants, with 36 in each group. The sample size estimate is based on a previous pilot study on acupuncture for endometriosis with a mean pain of 4.3, SD 1.2 (Armour et al., 2021), with a dropout rate of 20%, an assumed power of 80%, and an alpha of 5%. The aim is at least a 20% difference in overall daily pelvic pain severity from baseline to end of treatment between groups.
Comparisons are between verum vs control acupuncture. All analyses will be performed at a 5% significance level.
Baseline characteristics and all outcome variables will be described. Categorical data will be summarized by counts and proportions expressed as percentages. Continuous data will be summarized by mean, standard deviation, median, interquartile range, and range (minimum to maximum).
Both an intention-to-treat (ITT) and a per-protocol (PP) analysis will be carried out for the primary outcome to ensure robustness of the findings by giving a clear picture of the effect under real-world conditions (where not all people will complete a course of interventions) using an ITT analysis and under ideal conditions (where patients adhere to the protocol) as per PP analysis. The ITT dataset will include all participants according to the treatment they were randomized to. The PP analysis dataset will include participants who completed treatment per protocol. For all other statistical analyses, an ITT approach will be used.
Primary analysis of the primary outcome, overall pain, will be by ANCOVA with baseline overall pain as a continuous covariate.
Analysis of overall pain at all timepoints will be by linear mixed model for repeated measures by time, with a time by treatment interaction, time and group as fixed effects, and subject as a random effect.
Comparison of mean difference in menstrual and non-menstrual pain, quality of life scores, symptom scores, and treatment satisfaction will be by ANCOVA with baseline (where taken) as a continuous covariate.
Comparison of proportions (at least one AE; 20%, 30%, 50% reduction in overall pain) will be by logistic regression.
Comparison of number of days with rescue medication and number of adverse events will be by Poisson regression with an offset for the time of observation and a fixed effect for treatment. Overdispersion will be evaluated prior to analysis and corrected analysis applied if necessary.
For repeated measures analyses of continuous variables linear mixed models will be used, which assume missing data are missing at random. Otherwise, imputation will not be used.
The neutrophil to lymphocyte ratio and the platelet to lymphocyte ratio will be calculated from the complete neutrophil count, the complete lymphocyte count, and the complete platelet count from a complete blood count. Group comparisons will be performed by ANCOVA with baseline value as a continuous covariate. Normality will be assessed; if violated, data will be transformed where appropriate or analyzed using non-parametric methods if transformation is not suitable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/09/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
16/03/2027
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 44584 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 319744 0
University
Name [1] 319744 0
Western Sydney University
Country [1] 319744 0
Australia
Funding source category [2] 319889 0
Commercial sector/Industry
Name [2] 319889 0
Acuneeds
Country [2] 319889 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 322271 0
None
Name [1] 322271 0
Address [1] 322271 0
Country [1] 322271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318294 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 318294 0
Ethics committee country [1] 318294 0
Australia
Date submitted for ethics approval [1] 318294 0
01/05/2025
Approval date [1] 318294 0
18/08/2025
Ethics approval number [1] 318294 0
H16706

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

Contacts
Principal investigator
Name 143734 0
A/Prof Mike Armour
Address 143734 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead, NSW 2145
Country 143734 0
Australia
Phone 143734 0
+61 415363201
Fax 143734 0
Email 143734 0
[email protected]
Contact person for public queries
Name 143735 0
Nora Giese
Address 143735 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead, NSW 2145
Country 143735 0
Australia
Phone 143735 0
+61 419 600 427
Fax 143735 0
Email 143735 0
[email protected]
Contact person for scientific queries
Name 143736 0
Nora Giese
Address 143736 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead, NSW 2145
Country 143736 0
Australia
Phone 143736 0
+61 419 600 427
Fax 143736 0
Email 143736 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Contact person: Nora Giese
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.