The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients

NCT ID: NCT06438744

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2024-06-25

Brief 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. 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).

Conditions

Endometriosis-related Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

TEA combined with standard therapy

Group Type: EXPERIMENTAL

Thread embedding acupuncture (TEA) + standard therapy

Intervention Type: PROCEDURE

• 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Women aged 18-45 years.

2. Subjects diagnosed with endometriosis from laparoscopy, ultrasound, or histopathology.

3. Subjects experience at least one type of pain including pelvic pain, dysmenorrhoea, dyspareunia, dyschezia, or dysuria with a minimum NRS score of 4.

4. The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥4.

5. Subjects are willing to follow research procedures and sign the informed consent form.

Exclusion Criteria

1. Subjects who have wounds, inflammation, infection, lumps, or eczema at the puncture site.

2. Pregnant or breastfeeding women.

3. Subjects with blood clotting disorders or who are taking blood thinning medication.

4. Have a history of diabetes mellitus, malignancy, psychiatric disorders, keloids, allergies to stainless steel or PDO threads.

5. Subjects who received surgical therapy in the last 3 months.

6. Subjects who have been undergoing acupuncture therapy in the last 2 weeks or TEA in the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Marshellia Setiawan

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marshellia Setiawan, MD

Role: STUDY_DIRECTOR

Indonesia University

Locations

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

23-10-1610

Identifier Type: -

Identifier Source: org_study_id