Brief Title
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis
Official Title
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study
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 Type
Interventional
Primary Outcome
Chages in Visual Analogue Scale of subjective Pelvic Pain
Secondary Outcome
Health-related Quality of Life
Condition
Endometriosis
Intervention
acupuncture treatment
Study Arms / Comparison Groups
Acupuncture group
Description: twice a week, 6 weeks real acupuncture treatment, 12 sessions
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
30
Start Date
December 2010
Completion Date
September 2011
Primary Completion Date
September 2011
Eligibility Criteria
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
Gender
Female
Ages
16 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Jin-Moo Lee, OMD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01259180
Organization ID
KUIMS-pp-10
Study Sponsor
East West Neo Medical Center
Study Sponsor
Jin-Moo Lee, OMD, Study Director, East West Neo Medical Center
Verification Date
October 2010