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