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

Not Applicable

• Conditions: Endometriosis; Adenomyosis; Pelvic Pain
• Interventions: Procedure: acupuncture treatment; Procedure: Sham acupunture

• Registration Number: NCT01259180
• Lead Sponsor: East West Neo Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Posted: 2010-12-14
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	acupuncture treatment	twice a week, 6 weeks real acupuncture treatment, 12 sessions
Sham acupuncture group	Sham acupunture	twice a week, 6 weeks real acupuncture treatment, 12 sessions

Primary Outcome Measures

Name	Time	Method
Chages in Visual Analogue Scale of subjective Pelvic Pain	7wks

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life	7wks	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

Trial Locations

Locations (1)

East-West Neo Medical Center; 🇰🇷 Seoul, Korea, Republic of