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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by East West Neo Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
East West Neo Medical Center
ClinicalTrials.gov Identifier:
NCT01259180
First received: December 13, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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


Condition Intervention
Endometriosis
Adenomyosis
Pelvic Pain
 Procedure: acupuncture treatment
Procedure: Sham acupunture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by East West Neo Medical Center:

Primary Outcome Measures:
  • Chages in Visual Analogue Scale of subjective Pelvic Pain [ Time Frame: 7wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related Quality of Life [ Time Frame: 7wks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
observation.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259180

Locations
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     bromtom@naver.com    
Sponsors and Collaborators
East West Neo Medical Center
Investigators
Study Director: Jin-Moo Lee, OMD East West Neo Medical Center
  More Information

No publications provided

Responsible Party: Dae-Hyun Kim, East-West Neo Medical center clinical medicine institute
ClinicalTrials.gov Identifier: NCT01259180     History of Changes
Other Study ID Numbers: KUIMS-pp-10
Study First Received: December 13, 2010
Last Updated: December 13, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by East West Neo Medical Center:
acupuncture

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013