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

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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