The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jakarta
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Jakarta Pusat, Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 4.
- The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥4.
- Subjects are willing to follow research procedures and sign the informed consent form.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
TEA combined with standard therapy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale (NRS) score
Time Frame: 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. |
Before treatment, week 4, week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endometriosis Health Profile-30 (EHP-30) score
Time Frame: 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.
|
Before treatment, week 4, week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marshellia Setiawan, MD, Indonesia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-10-1610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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