The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS) score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥
- •Subjects are willing to follow research procedures and sign the informed consent form.
排除标准
- •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.
结局指标
主要结局
Numeric rating scale (NRS) score
时间窗: 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.
次要结局
- Endometriosis Health Profile-30 (EHP-30) score(Before treatment, week 4, week 8)
研究者
Marshellia Setiawan
Medical Doctor
Indonesia University