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

East West Neo Medical Center

Status: Unknown

Conditions: Pelvic Pain; Adenomyosis; Endometriosis

Treatments: Procedure: acupuncture treatment; Procedure: Sham acupunture

Study type: Interventional

Funder types: Other

Identifiers

NCT01259180

KUIMS-pp-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Acupuncture group

Experimental group

Description:

twice a week, 6 weeks real acupuncture treatment, 12 sessions

Treatment:

Procedure: acupuncture treatment

Sham acupuncture group

Sham Comparator group

Description:

twice a week, 6 weeks real acupuncture treatment, 12 sessions

Treatment:

Procedure: Sham acupunture

Control group

No Intervention group

Description:

observation.