Vitamin K Injections for the Treatment of Painful Menstruation - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00104546

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 I

MedlinePlus related topics: Acupuncture Menstruation

Drug Information available for: Vitamin K

U.S. FDA Resources

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 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

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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Fredi Kronenberg, PhD

Columbia University College of Physicians and Surgeons

More Information

Study ID Numbers:	R21 AT001957
Study First Received:	March 1, 2005
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00104546
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

Study placed in the following topic categories:

Signs and Symptoms
Antiplasmin
Pelvic Pain
Menstruation Disturbances

Dysmenorrhea
Vitamin K
Pain

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Coagulants
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics

Fibrin Modulating Agents
Pathologic Processes
Antifibrinolytic Agents
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009