Clinical trial NCT01259180: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Adenomyosis
Pelvic Pain
Keywords: acupuncture
Lead sponsor: East West Neo Medical Center
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chages in Visual Analogue Scale of subjective Pelvic Pain
timeFrame: 7wks
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: 7wks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: East-West Neo Medical Center
Study officials:
affiliation: East West Neo Medical Center
name: Jin-Moo Lee, OMD
role: STUDY_DIRECTOR
References: