Clinical Trial: Vitamin K Injections for the Treatment of Painful Menstruation

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation.

Condition Treatment or Intervention Phase
Dysmenorrhea
 Procedure: Acupuncture point injection of vitamin K
Phase I

MedlinePlus related topics:  Menstruation

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study

Further Study Details: 
Primary Outcomes: Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS); presence and severity of recurrences of menstrual pain pre- and post-treatment and in 5 subsequent cycles after therapy; Cox retrospective symptom scale; Moos score
Expected Total Enrollment:  36

Study start: September 2004;  Expected completion: December 2006
Last follow-up: December 2005;  Data entry closure: March 2006

Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs (NSAIDS) and oral contraceptives are the most commonly prescribed treatments for this condition. However, in China, oral contraceptives are not commonly prescribed for unmarried women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture points, has become standard treatment for dysmenorrhea at many Chinese health care facilities. This trial will assess the willingness of young Chinese women to participate in an acu-injection trial, explore the utility of pain measurements after injection, and determine the effectiveness of the injections. This study will also help in planning larger acu-injection clinical trials.

This study will last for five menstrual cycles. Participants will be randomly assigned to one of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 2 participants will receive a saline injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture point of both legs and a vitamin K3 injection in the right buttock. Injections will be administered one time during the first 2 days of the first menstrual cycle for participants who are experiencing menstrual pain. Participants will record their level of menstrual pain before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not respond to or are not satisfied with the acu-injection treatment will be offered either Chinese herbal medicine or NSAIDS within 1 hour of the injection. After the injection visit, participants will be asked to complete questionnaires about any menstrual pain or side effects they may be experiencing for five subsequent menstrual cycles.

Eligibility

Ages Eligible for Study:  14 Years   -   25 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

  • Dysmenorrhea for at least 6 months prior to study entry
  • Have never been pregnant or have given birth
  • Mandarin Chinese or Shanghainese speaking
  • Regular menstrual cycles for at least 6 months prior to diagnosis of dysmenorrhea
  • Has a working home phone or cellular phone
  • Willing to disclose address
  • Intends to stay in the area during the study
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Dysmenorrhea due to any suspected or recognized causes
  • Current use of hormonal contraceptives or an intrauterine device
  • History of abdominal surgery
  • Other concomitant therapy for acute or chronic pain
  • Anticoagulant drugs
  • Vitamin K acu-injections at leg acupuncture points prior to study entry
  • Intolerance to NSAIDs
  • Known allergy to vitamin K

Location and Contact Information

Fredi Kronenberg, PhD      212-342-0111    fk11@columbia.edu
Christine Wade, MPH      212-342-0105    wade@columbia.edu

China
      Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University, Shanghai,  China; Recruiting
Suiqi Gui, MD  86-21-6377 0161    sqgui@hotmail.com 
Congjian Xu, MD  86-21-63455050  Ext. 263    xucj@vnet.citiz.net 
Fredi Kronenberg, PhD,  Principal Investigator
Suiqi Gui, MD,  Principal Investigator
Christine Wade, MPH,  Sub-Investigator
Li Wang, MD,  Sub-Investigator
Francesco Cardini, MD,  Sub-Investigator

Study chairs or principal investigators

Fredi Kronenberg, PhD,  Principal Investigator,  Columbia University   

More Information

Study ID Numbers:  R21-AT001957
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  March 1, 2005
ClinicalTrials.gov Identifier:  NCT00104546
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources