Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis

Study Overview
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Brief Summary
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The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain in women with endometriosis or adenomyosis.

Detailed Description
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Chronic pelvic pain(CPP) is a common disease among women, and its prevalence ranges from 4 to 25 percent. There are various conditions associated with CPP, including gynecologic, urologic and gastointestinal problems. Endometriosis is the most common diagnosis made at the time of gynecological laparoscopy performed to evaluate CPP. Treatments of CPP with endometriosis include medical(analgesics, oral contraceptive pills, gonadotropin releasing hormone(GnRH) agonist, etc.), surgical and combined treatment. Progestins, danazol, estrogen-progestin pills, or GnRH agonists are commonly used as a concurrent treatment along with surgery. However, a systematic review on the comparison of postsurgical hormonal suppression to surgery alone concluded that, while postoperative medical therapy decreased recurrence rates, there was no significant benefit on the outcomes of pain and pregnancy rates. Therefore there is a need for postoperaive medical therapy for pain relief. In this study, the investigators propose a randomized, sham-controlled trial to investigate the efficacy of acupuncture as a pain control for the patients dignosed endometriosis during laparoscopic surgery due to CPP, and have been on 6 month-scheduled GnRH agonist treatment as a postoperative treatment.

Official Title
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Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study

Conditions
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Endometriosis, Adenomyosis, Pelvic Pain

Intervention / Treatment
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* Procedure: acupuncture treatment
* Procedure: Sham acupunture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had undergone laparoscopic surgery due to pelvic pain Patients who have been on GnRH agonist treatment for 6 months after being diagnosed Endometriosis or Adenomyosis Patients who agreed a written consent by their own will Patients' compliance and geographical adjacency appropriate for proper follow up survey continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks of surgery) (0='no pain', '10=most severe') Exclusion Criteria: Those who had taken hormones or drugs that can affect diagnosis of endometriosis or adenomyosis for past 1 year Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during surgery Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy, epilepsy) Unable to participate in clinical trial by doctor's judgment irritable bowel syndrome

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>twice a week, 6 weeks real acupuncture treatment, 12 sessions | Procedure: acupuncture treatment<br>* twice a week, 6 weeks, 12sessions penetrating skin with stailess steel acupuncture device(diameter: 0.25-0.3mm,legth: 30-70mm) points: BL 23,BL31,BL32, BL40, BL53, GB30, SP 6 bilaterally plus Ashi. with<br>|
| Sham Comparator: Sham acupuncture group<br>twice a week, 6 weeks real acupuncture treatment, 12 sessions | Procedure: Sham acupunture<br>* twice a week, 6 weeks, 12 sessions not penetrating skin with dull acupuncture device(Park Sham device :Acuprime Co. Ltd, UK) point: 1 2inches away from real acupuncture point<br>|
| No Intervention: Control group<br>observation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chages in Visual Analogue Scale of subjective Pelvic Pain |  | 7wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life | 1.36-item Short-Form Health Survey Version 2.0 2.Beck's Depression Index 3.Social Readjustment Rating Scale 4. Heart Rate Variability 5. Digital Infrared Thermographic Image 6. Assessment of Voice | 7wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture