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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis-related Pain
• Intervention / Treatment: Procedure: Thread embedding acupuncture (TEA) + standard therapy

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; TEA combined with standard therapy	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before treatment, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before treatment, week 4, week 8

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Study Director: Marshellia Setiawan, MD, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pain; acupuncture; endometriosis; thread embedding acupuncture; ehp30
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 23-10-1610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No