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

Endometriosis-related Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438744
• Other study ID #: 23-10-1610
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Indonesia University
• Contact: Marshellia Setiawan, MD
• Phone: 6281221792616
• Email: setiawanmarshellia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis-related Pain

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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