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

December 13, 2010
December 13, 2010
December 2010
September 2011   (final data collection date for primary outcome measure)
Chages in Visual Analogue Scale of subjective Pelvic Pain [ Time Frame: 7wks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Endometriosis
  • Adenomyosis
  • Pelvic Pain
  • 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
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
16 Years to 55 Years
No
Not Provided
Korea, Republic of
 
NCT01259180
KUIMS-pp-10
No
Dae-Hyun Kim, East-West Neo Medical center clinical medicine institute
East West Neo Medical Center
Not Provided
Study Director: Jin-Moo Lee, OMD East West Neo Medical Center
East West Neo Medical Center
October 2010

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