Vitamin K Injections for the Treatment of Painful Menstruation

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104546
• Other study ID #: R21AT001957
• Status: Completed
• Phase: Phase 1
• First received: March 1, 2005
• Last updated: January 23, 2008
• Start date: September 2004
• Est. completion date: March 2006

Study information

• Verified date: January 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 25 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Procedure:
• Acupuncture point injection of vitamin K

Locations

Country	Name	City	State
China	Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS)
Primary	presence and severity of recurrences of menstrual pain pre- and post-treatment and in 5 subsequent cycles after therapy
Primary	Cox retrospective symptom scale
Primary	Moos score