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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2005

Last Updated Date

January 23, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00104546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Vitamin K Injections for the Treatment of Painful Menstruation

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Dysmenorrhea

Intervention ^ICMJE

Procedure: Acupuncture point injection of vitamin K

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00104546

Other Study ID Numbers ^ICMJE

R21 AT001957

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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