Clinical trial NCT06438744: The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
Official title: The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis-related Pain
Keywords: endometriosis
pain
ehp30
acupuncture
thread embedding acupuncture
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-group pretest-posttest clinical trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric rating scale (NRS) score
timeFrame: Before treatment, week 4, week 8
Secondary outcomes:
measure: Endometriosis Health Profile-30 (EHP-30) score
timeFrame: Before treatment, week 4, week 8
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Indonesia University
name: Marshellia Setiawan, MD
role: STUDY_DIRECTOR
References: