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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis; Pelvic Pain; Adenomyosis
• Intervention / Treatment: Procedure: acupuncture treatment; Procedure: Sham acupunture

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 134-727
    • East-west neo medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Chages in Visual Analogue Scale of subjective Pelvic Pain	7wks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life	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	7wks

Collaborators and Investigators

• Sponsor: East West Neo Medical Center
• Investigators: Study Director: Jin-Moo Lee, OMD, East West Neo Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Uterine Diseases; Endometriosis; Adenomyosis; Pelvic Pain
• Other Study ID Numbers: KUIMS-pp-10