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

NCT01259180 | Unknown

• 1 other identifier: KUIMS-pp-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis; Adenomyosis; Pelvic Pain

Keywords

acupuncture

Outcome Measures

Primary Outcomes (1)

• Chages in Visual Analogue Scale of subjective Pelvic Pain

  7wks

Secondary Outcomes (1)

• Health-related Quality of Life

  7wks

Study Arms (3)

Acupuncture group

EXPERIMENTAL

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

Procedure: acupuncture treatment

Sham acupuncture group

SHAM COMPARATOR

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

Procedure: Sham acupunture

Control group

NO INTERVENTION

observation.

Interventions

acupuncture treatment 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

Acupuncture group

Sham acupunture 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

Sham acupuncture group

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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')

You may not qualify if:

• 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

Sponsors & Collaborators

• East West Neo Medical Center: lead

Study Sites (1)

East-West Neo Medical Center

Seoul, Seoul, 134-727, South Korea

Location

MeSH Terms

Conditions

Endometriosis; Adenomyosis; Pelvic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jin-Moo Lee, OMD

  East West Neo Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 14, 2010

Record last verified: 2010-10

Locations

KR (1)