Endometriosis-related Pain
Conditions
Keywords
endometriosis, pain, ehp30, acupuncture, thread embedding acupuncture
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).
Interventions
PROCEDUREThread 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
Sponsors
Indonesia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One-group pretest-posttest clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Endometriosis Health Profile-30 (EHP-30) score | 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. |
Countries
Indonesia
Outcome results
None listed