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

NCT ID: NCT01259180

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometriosis Adenomyosis Pelvic Pain

Keywords

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acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Acupuncture group

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

Group Type EXPERIMENTAL

acupuncture treatment

Intervention Type PROCEDURE

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 acupuncture group

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

Group Type SHAM_COMPARATOR

Sham acupunture

Intervention Type PROCEDURE

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

Control group

observation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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East West Neo Medical Center

OTHER

Sponsor Role lead

Responsible Party

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East-West Neo Medical center clinical medicine institute

Principal Investigators

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Jin-Moo Lee, OMD

Role: STUDY_DIRECTOR

East West Neo Medical Center

Locations

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East-West Neo Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Facility Contacts

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Ji Yung Lee, OMD

Role: primary

Other Identifiers

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KUIMS-pp-10

Identifier Type: -

Identifier Source: org_study_id