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

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.

Study Type: Interventional

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

Study Primary Completion Date: 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.

Intervention(s) in this Clinical Trial

• Procedure: Acupuncture point injection of vitamin K

Primary 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

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 14 Years

Maximum Age for this Clinical Trial: 25 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Center for Complementary and Alternative Medicine (NCCAM)

Overall Clinical Trial Officials and Contacts

Fredi Kronenberg, PhD Principal Investigator Columbia University College of Physicians and Surgeons  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00104546

Study ID Number: R21 AT001957

ClinicalTrials.gov Identifier: NCT00104546

Health Authority: United States: Federal Government