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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01259180
Recruitment Status : Unknown
Verified October 2010 by East West Neo Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 14, 2010
Last Update Posted : December 14, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Endometriosis Adenomyosis Pelvic Pain Procedure: acupuncture treatment Procedure: Sham acupunture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study
Study Start Date : December 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acupuncture group
twice a week, 6 weeks real acupuncture treatment, 12 sessions
Procedure: acupuncture treatment
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

Sham Comparator: Sham acupuncture group
twice a week, 6 weeks real acupuncture treatment, 12 sessions
Procedure: Sham acupunture
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

No Intervention: Control group

Primary Outcome Measures :
  1. Chages in Visual Analogue Scale of subjective Pelvic Pain [ Time Frame: 7wks ]

Secondary Outcome Measures :
  1. Health-related Quality of Life [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01259180

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Korea, Republic of
East-West Neo Medical Center Not yet recruiting
Seoul, Korea, Republic of, 134-727
Contact: Ji Yung Lee, OMD    82-2-440-7128   
Sponsors and Collaborators
East West Neo Medical Center
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Study Director: Jin-Moo Lee, OMD East West Neo Medical Center

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Responsible Party: Dae-Hyun Kim, East-West Neo Medical center clinical medicine institute Identifier: NCT01259180     History of Changes
Other Study ID Numbers: KUIMS-pp-10
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: October 2010
Keywords provided by East West Neo Medical Center:
Additional relevant MeSH terms:
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Pelvic Pain
Genital Diseases, Female
Neurologic Manifestations
Signs and Symptoms
Uterine Diseases