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A Pilot Study of Acupoint Injection for Primary Dysmenorrhea (DAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00995917
First received: October 14, 2009
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K into an acupuncture point has been used as treatment for dysmenorrhea at the Obstetrics & Gynecology Hospital in Shanghai, China since at least 1985. More research is needed on the effectiveness of this treatment and its acceptability to different women. The objective of this study is to examine the feasibility and effectiveness of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the United States. Twenty participants will be randomized to receive either 1) vitamin K1 injection into an acupuncture point at the start of their menstrual cycle followed by a saline injection in a non-acupuncture point two months later or 2) saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months later. The primary outcome measure will be change in pain intensity measured before and after each treatment. Data on other menstrual symptoms will be collected by telephone or a web-based survey. Three additional participants will be recruited to receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and after injection to determine absorption of vitamin K1. The aims of the study are to collect preliminary data on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S. women; and test the blood absorption of vitamin K1 following acupoint injection treatment.

The investigators hypothesize that:

  1. Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.
  2. Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection does.
  3. The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.
  4. Vitamin K1 is absorbed into the blood thru acupoint injection.

Condition Intervention
Dysmenorrhea
Pain, Menstrual
 Other: Vitamin K acupoint injection
Other: Saline Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Crossover, Pilot Trial of the Feasibility and Safety of Acupoint Injection of Vitamin K for Treatment of Primary Dysmenorrhea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • self-reported pain [ Time Frame: 3-5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • medications used during menstrual cycle [ Time Frame: 3-5 months ] [ Designated as safety issue: No ]
  • activity restriction [ Time Frame: 3-5 months ] [ Designated as safety issue: No ]
  • vitamin K content in blood [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]
  • Cox retrospective symptom scale [ Time Frame: 3-5 months ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin K acupoint injection
Participants will receive the vitamin K intervention within 2 days of the onset of painful menstrual cramps.
 Other: Vitamin K acupoint injection
Vitamin K will be injected into an acupuncture point within 2 days of the onset of painful menstrual cramps. Injections of 5 mg/0.5ml of vitamin K1 will be administered in bilateral acupuncture points. A single shot of vitamin K1 is 10mg/ml. Five mg/0.5ml will be drawn twice from one ampule and injected into each bilateral site, for a total dose of 10mg/ml of vitamin K.
Sham Comparator: Saline Injection
Participants will receive the saline treatment within 2 days of the onset of painful menstrual cramps.
 Other: Saline Injection
Injection of .5ml saline bilaterally into both legs within 2 days of the onset of painful menstrual cramps.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young women age 18-25
  • Severe primary dysmenorrhea (defined as severe, recurrent painful periods for 6 months or more, that are not due to any other diagnosis, and that have not been relieved, or have been only partially relieved by any other treatment)
  • Nulliparous
  • English speaking
  • No acute or chronic conditions diagnosed or suspected
  • Not on hormonal contraceptives
  • Regular menstrual cycles for at least 6 months
  • Has a working phone or pager

Exclusion Criteria:

  • Use of hormonal contraceptives, or intra-uterine device
  • Pregnancy
  • Dysmenorrhea due to any other suspected or recognized causes
  • History of abdominal surgery
  • Participation in other concomitant therapy for acute or chronic pain
  • Current treatment with anti-coagulant drugs for any reason
  • Previous treatment with vitamin K acupoint injection
  • Plans to be out of area during next 5 months
  • Under age 18
  • Known allergy to Vitamin K.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995917

Locations
United States, California
Mount Zion Outpatient Unit
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Maria Chao, Dr PH, MPA University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00995917     History of Changes
Other Study ID Numbers: A112809
Study First Received: October 14, 2009
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
acupuncture
menstrual pain
dysmenorrhea
menstrual cramps
vitamin K1

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Vitamin K 1
Vitamin K
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013