Vitamin K Injections for the Treatment of Painful Menstruation

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00104546
First received: March 1, 2005
Last updated: January 23, 2008
Last verified: January 2008
  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 Intervention Phase
Dysmenorrhea
Procedure: Acupuncture point injection of vitamin K
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 36
Study Start Date: September 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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 to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104546

Locations
China
Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University
Shanghai, China
Sponsors and Collaborators
Investigators
Principal Investigator: Fredi Kronenberg, PhD Columbia University College of Physicians and Surgeons
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104546     History of Changes
Other Study ID Numbers: R21 AT001957
Study First Received: March 1, 2005
Last Updated: January 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Dysmenorrhea
Acupuncture
Vitamin K
Medicine, Chinese Traditional
Women
Menstruation
Pain, Menstrual
China

Additional relevant MeSH terms:
Menstruation Disturbances
Dysmenorrhea
Pain
Pathologic Processes
Pelvic Pain
Signs and Symptoms
Vitamin K
Vitamins
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014