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

Not Applicable

Completed

• Conditions: Endometriosis-related Pain
• Interventions: Procedure: Thread embedding acupuncture (TEA) + standard therapy

• Registration Number: NCT06438744
• Lead Sponsor: Indonesia University

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).

Study Timeline

• Study Start: 2023-12-18
• Status Verified: 2024-05
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Study First Posted: 2024-06-03
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Thread embedding acupuncture (TEA) + standard therapy	TEA combined with standard therapy

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS) score	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.

Secondary Outcome Measures

Name	Time	Method
Endometriosis Health Profile-30 (EHP-30) score	Before treatment, week 4, week 8	Questionnaire measuring quality of life related to health status, specific for patients with endometriosis. The larger the number, the worse the health status.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia