Endometriosis-related PainNCT06438744
The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
A study testing Thread embedding acupuncture (TEA) + standard therapy in people with Endometriosis-related Pain, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Endometriosis is a common gynecological problem, with pain as the main problem. Pain can be felt for years, in high intensity, continuous, unpredictable, and disrupts the patient's daily life, thereby reducing the quality of life. Dienogest is a progestin-derived drug, the first line therapy for endometriosis pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis-related Pain
- What is being tested?
- Thread embedding acupuncture (TEA) + standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Dec 2023to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years.
- Subjects diagnosed with endometriosis from laparoscopy, ultrasound, or histopathology.
- Subjects experience at least one type of pain including pelvic pain, dysmenorrhoea, dyspareunia, dyschezia, or dysuria with a minimum NRS score of 4.
- The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥4.
- Subjects are willing to follow research procedures and sign the informed consent form.
Who cannot join
- Subjects who have wounds, inflammation, infection, lumps, or eczema at the puncture site.
- Pregnant or breastfeeding women.
- Subjects with blood clotting disorders or who are taking blood thinning medication.
- Have a history of diabetes mellitus, malignancy, psychiatric disorders, keloids, allergies to stainless steel or PDO threads.
- Subjects who received surgical therapy in the last 3 months.
- Subjects who have been undergoing acupuncture therapy in the last 2 weeks or TEA in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Endometriosis is a common gynecological problem, with pain as the main problem. Pain can be felt for years, in high intensity, continuous, unpredictable, and disrupts the patient's daily life, thereby reducing the quality of life. Dienogest is a progestin-derived drug, the first line therapy for endometriosis pain. Other therapy options include hormonal, non-hormonal therapy, and surgery, but they have a high risk of side effects and recurrence.
In cases of endometriosis, acupuncture has an analgesic effect, modulates hormones and neurotransmitters, strengthens immune cells, and reduces inflammation, therefore improves quality of life. However, the effectiveness of thread embedding acupuncture for endometriosis pain is still rarely published. This research was conducted to determine the effectiveness of thread embedding acupuncture for pain and quality of life in endometriosis patients.
Read the detailed description
This study is a one-group pretest-posttest clinical trial. Research subjects will receive a one-time thread embedding acupuncture (TEA) combined with dienogest as standard therapy for 8 weeks. The outcomes assessed will be pain intensity (NRS score) and quality of life score (Endometriosis Health Profile-30 core score) 4 and 8 weeks after receiving TEA combined with standard therapy (posttest), compared with standard therapy alone (pretest).
- Conditions
- Endometriosis-related Pain
- Being tested
- Thread embedding acupuncture (TEA) + standard therapy
- Keywords
- endometriosis, pain, ehp30, acupuncture, thread embedding acupuncture
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread embedding acupuncture (TEA) + standard therapyProcedure or surgery
- TEA : one-time TEA using 30 gauge TEA needle with 30 mm polydioxanone thread at CV3 through CV4, SP6 and ST36 bilaterally
- Standard therapy : 2 mg dienogest daily for 8 weeks after TEA
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | TEA combined with standard therapy Receives: Procedure: Thread embedding acupuncture (TEA) + standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) score
Pain intensity measurement scale consists of 11 points (0-10). The higher the score, the more severe the pain intensity.
A score of 0 means there is no pain at all, while a score of 10 means the pain is unbearable.
Measured: Before treatment, week 4, week 8
Secondary outcomes (1)
Endometriosis Health Profile-30 (EHP-30) score
Questionnaire measuring quality of life related to health status, specific for patients with endometriosis. The larger the number, the worse the health status.
Measured: Before treatment, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start18 Dec 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis-related PainStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-group pretest-posttest clinical trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marshellia Setiawan, Universitas Indonesia
- Investigators
- Marshellia Setiawan, MD, Study director, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438744
- Sponsor's protocol ID
- 23-10-1610
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
- ClinicalTrials.gov ID
- NCT06438744
- Acronym / sponsor ID
- 23-10-1610
- Conditions
- Endometriosis-related Pain
- Keywords
- endometriosis, pain, ehp30, acupuncture, thread embedding acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endometriosis is a common gynecological problem, with pain as the main problem. Pain can be felt for years, in high intensity, continuous, unpredictable, and disrupts the patient's daily life, thereby reducing the quality of life. Dienogest is a progestin-derived drug, the first line therapy for endometriosis pain. Other therapy options include hormonal, non-hormonal therapy, and surgery, but they have a high risk of side effects and recurrence.
In cases of endometriosis, acupuncture has an analgesic effect, modulates hormones and neurotransmitters, strengthens immune cells, and reduces inflammation, therefore improves quality of life. However, the effectiveness of thread embedding acupuncture for endometriosis pain is still rarely published. This research was conducted to determine the effectiveness of thread embedding acupuncture for pain and quality of life in endometriosis patients.
Detailed description
This study is a one-group pretest-posttest clinical trial. Research subjects will receive a one-time thread embedding acupuncture (TEA) combined with dienogest as standard therapy for 8 weeks. The outcomes assessed will be pain intensity (NRS score) and quality of life score (Endometriosis Health Profile-30 core score) 4 and 8 weeks after receiving TEA combined with standard therapy (posttest), compared with standard therapy alone (pretest).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-group pretest-posttest clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Thread embedding acupuncture (TEA) + standard therapyTEA combined with standard therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-45 years.
- Subjects diagnosed with endometriosis from laparoscopy, ultrasound, or histopathology.
- Subjects experience at least one type of pain including pelvic pain, dysmenorrhoea, dyspareunia, dyschezia, or dysuria with a minimum NRS score of 4.
- The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥4.
- Subjects are willing to follow research procedures and sign the informed consent form.
Key exclusion criteria (6 listed)
- Subjects who have wounds, inflammation, infection, lumps, or eczema at the puncture site.
- Pregnant or breastfeeding women.
- Subjects with blood clotting disorders or who are taking blood thinning medication.
- Have a history of diabetes mellitus, malignancy, psychiatric disorders, keloids, allergies to stainless steel or PDO threads.
- Subjects who received surgical therapy in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thread embedding acupuncture (TEA) + standard therapy* TEA : one-time TEA using 30 gauge TEA needle with 30 mm polydioxanone thread at CV3 through CV4, SP6 and ST36 bilaterally * Standard therapy : 2 mg dienogest daily for 8 weeks after TEA | Procedure or surgery | Experimental |
Primary outcome
Numeric rating scale (NRS) score
Time frame: Before treatment, week 4, week 8
Pain intensity measurement scale consists of 11 points (0-10). The higher the score, the more severe the pain intensity. A score of 0 means there is no pain at all, while a score of 10 means the pain is unbearable.
1 secondary outcome
Endometriosis Health Profile-30 (EHP-30) score
Time frame: Before treatment, week 4, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshellia Setiawan, MD study director
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread embedding acupuncture (TEA) + standard therapy in people with Endometriosis-related Pain, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) score (time frame: Before treatment, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.