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

Primary Purpose

Endometriosis, Adenomyosis, Pelvic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture treatment
Sham acupunture
Sponsored by
East West Neo Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring acupuncture

Eligibility Criteria

16 Years - 55 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • East-West Neo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Acupuncture group

Sham acupuncture group

Control group

Arm Description

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

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

observation.

Outcomes

Primary Outcome Measures

Chages in Visual Analogue Scale of subjective Pelvic Pain

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2010
Last Updated
December 13, 2010
Sponsor
East West Neo Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01259180
Brief Title
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

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
East West Neo Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Adenomyosis, Pelvic Pain
Keywords
acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
twice a week, 6 weeks real acupuncture treatment, 12 sessions
Arm Title
Sham acupuncture group
Arm Type
Sham Comparator
Arm Description
twice a week, 6 weeks real acupuncture treatment, 12 sessions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
observation.
Intervention Type
Procedure
Intervention Name(s)
acupuncture treatment
Intervention Description
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
Intervention Name(s)
Sham acupunture
Intervention Description
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
Primary Outcome Measure Information:
Title
Chages in Visual Analogue Scale of subjective Pelvic Pain
Time Frame
7wks
Secondary Outcome Measure Information:
Title
Health-related Quality of Life
Description
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
Time Frame
7wks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Moo Lee, OMD
Organizational Affiliation
East West Neo Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
East-West Neo Medical Center
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yung Lee, OMD
Phone
82-2-440-7128
Email
bromtom@naver.com

12. IPD Sharing Statement

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

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