Vitamin K Injections for the Treatment of Painful Menstruation - Tabular View

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Vitamin K Injections for the Treatment of Painful Menstruation

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Vitamin K Injections for the Treatment of Painful Menstruation

Official Title ^†

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

Brief Summary

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.

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

Condition ^†

Dysmenorrhea

Intervention ^†

Procedure: Acupuncture point injection of vitamin K

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2004

Completion Date

March 2006

Eligibility 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

Gender

Female

Ages

14 Years to 25 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

China

Administrative Information Fields

NCT ID ^†

NCT00104546

Organization ID

R21 AT001957

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Fredi Kronenberg, PhD

Columbia University College of Physicians and Surgeons

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2008

First Received Date ^†

March 1, 2005

Last Updated Date

January 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.