Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | TEA combined with standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thread embedding acupuncture (TEA) + standard therapy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marshellia Setiawan, MD | Indonesia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013662 | Tea |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
Not provided
Not provided
One-group pretest-posttest clinical trial
Not provided
Not provided
Not provided
Not provided
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |