The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
Launched by INDONESIA UNIVERSITY · May 27, 2024
Trial Information
Current as of February 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a special type of acupuncture called thread embedding acupuncture on pain and quality of life for women suffering from endometriosis. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, often causing significant pain that can disrupt daily life. While some medications, like dienogest, can help manage this pain, many women still experience discomfort. The trial aims to see if thread embedding acupuncture can provide additional relief and improve quality of life for these patients.
To participate in the study, women aged 18 to 45 who have been diagnosed with endometriosis and are still experiencing moderate to severe pain (rated 4 or higher on a pain scale) after at least one month of dienogest treatment may be eligible. Participants will need to agree to follow the study procedures and provide informed consent. It's important to note that certain individuals, like those with specific health conditions, recent surgeries, or those who are pregnant or breastfeeding, will not be able to participate. If eligible, participants can expect to receive acupuncture treatment and help researchers learn more about alternative pain management options for endometriosis.
Gender
FEMALE
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.
Trial Officials
Marshellia Setiawan, MD
Study Director
Indonesia University
About Indonesia University
Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jakarta Pusat, Jakarta, Indonesia
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0