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Completed

NCT Number: NCT06438744

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Endometriosis Health Profile-30 (EHP-30) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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