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

Endometriosis Clinical Trial

Official title:

Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01259180
• Other study ID #: KUIMS-pp-10
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2010
• Last updated: December 13, 2010
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2010
• Source: East West Neo Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenomyosis
• Endometriosis
• Pelvic Pain

Intervention

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 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

Locations

Country	Name	City	State
Korea, Republic of	East-West Neo Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
East West Neo Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chages in Visual Analogue Scale of subjective Pelvic Pain		7wks	No
Secondary	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	No