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

NCT06438744 | Completed DMC

• 1 other identifier: 23-10-1610
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis-related Pain

Keywords

endometriosis; pain; ehp30; acupuncture; thread embedding acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Endometriosis Health Profile-30 (EHP-30) score

  Before treatment, week 4, week 8

Study Arms (1)

Experimental

EXPERIMENTAL

TEA combined with standard therapy

Procedure: Thread embedding acupuncture (TEA) + standard therapy

Interventions

Thread embedding acupuncture (TEA) + standard therapy 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

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Endometriosis; Pain

Interventions

Tea; Standard of Care

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marshellia Setiawan, MD

  Indonesia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: One-group pretest-posttest clinical trial

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: December 18, 2023
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: May 6, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)