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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
East West Neo Medical Center

Tracking Information
First Submitted Date  ICMJE December 13, 2010
First Posted Date  ICMJE December 14, 2010
Last Update Posted Date December 14, 2010
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
Chages in Visual Analogue Scale of subjective Pelvic Pain [ Time Frame: 7wks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometriosis
  • Adenomyosis
  • Pelvic Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Acupuncture group
    twice a week, 6 weeks real acupuncture treatment, 12 sessions
    Intervention: Procedure: acupuncture treatment
  • Sham Comparator: Sham acupuncture group
    twice a week, 6 weeks real acupuncture treatment, 12 sessions
    Intervention: Procedure: Sham acupunture
  • No Intervention: Control group
    observation.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 13, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01259180
Other Study ID Numbers  ICMJE KUIMS-pp-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dae-Hyun Kim, East-West Neo Medical center clinical medicine institute
Study Sponsor  ICMJE East West Neo Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jin-Moo Lee, OMD East West Neo Medical Center
PRS Account East West Neo Medical Center
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP