Effectiveness of two different acupuncture strategies in patients with vulvodynia Study protocol for a pilot pragmatic controlled trial  

作　　者：Arthur Yin Fan Sarah F.Alemi Yingping H.Zhu Sudaba Rahimi Hui Wei Haihe Tian Deguang He Changzhen Gong Guanhu Yang Chong He Hui Ouyang 

机构地区：[1]American Traditional Chinese Medicine Association,Vienna,VA 22182,USA [2]McLean Center for Complementary and Alternative Medicine,PLC.,Vienna,VA 22182,USA

出　　处：《Journal of Integrative Medicine》2018年第6期384-389,共6页结合医学学报（英文版）

摘　　要：Background： Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementary and integrative medicine therapy used by some patients with vulvodynia. This study evaluates two different acupuncture strategies for the treatment of vulvodynia and aims to evalu- ate whether either of the acupuncture protocols reduces vulvar pain, pain duration or pain with inter- course. The study also examines how long the effect of acupuncture lasts in women with vulvodynia. Methods/design： The study is designed as a randomized controlled trial, focused on two acupuncture protocols. Fifty-one patients who have had vulvodynia for more than 3 months will be recruited. Among them, 34 patients will be randomized into Groups la and 1b; those who are unwilling to receive acupuncture will be recruited into the standard care group （Group 2）. Patients in Group la will have acupuncture focused on the points in the pudendal nerve distribution area, while patients in Group lb will receive acupuncture focused on traditional （distal） meridian points. Patients in Group 2 will receive routine conventional treatments, such as using pain medications, local injections and physical therapies or other nonsurgical procedures. Acupuncture will last 45 min per session, once or twice a week for 6 weeks. The primary outcome measurement will be objective pain intensity, using the cotton swab test. The secondary outcome measurement will be subjective patient self-reported pain intensity, which will be conducted before cotton swab test. Pain intensities will be measured by an 11-point Numeric Pain Rating Scale. Pain duration and pain score during intercourse are recorded. Local muscle tension, tender- ness and trigger points （Ashi points） are also recorded. All measurements will be recorded at baseline （before the treatment）, at the end of each week during treatment and at the end of the 6weeks. FollowBackground： Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementary and integrative medicine therapy used by some patients with vulvodynia. This study evaluates two different acupuncture strategies for the treatment of vulvodynia and aims to evalu- ate whether either of the acupuncture protocols reduces vulvar pain, pain duration or pain with inter- course. The study also examines how long the effect of acupuncture lasts in women with vulvodynia. Methods/design： The study is designed as a randomized controlled trial, focused on two acupuncture protocols. Fifty-one patients who have had vulvodynia for more than 3 months will be recruited. Among them, 34 patients will be randomized into Groups la and 1b; those who are unwilling to receive acupuncture will be recruited into the standard care group （Group 2）. Patients in Group la will have acupuncture focused on the points in the pudendal nerve distribution area, while patients in Group lb will receive acupuncture focused on traditional （distal） meridian points. Patients in Group 2 will receive routine conventional treatments, such as using pain medications, local injections and physical therapies or other nonsurgical procedures. Acupuncture will last 45 min per session, once or twice a week for 6 weeks. The primary outcome measurement will be objective pain intensity, using the cotton swab test. The secondary outcome measurement will be subjective patient self-reported pain intensity, which will be conducted before cotton swab test. Pain intensities will be measured by an 11-point Numeric Pain Rating Scale. Pain duration and pain score during intercourse are recorded. Local muscle tension, tender- ness and trigger points （Ashi points） are also recorded. All measurements will be recorded at baseline （before the treatment）, at the end of each week during treatment and at the end of the 6weeks. Follow

关 键 词：ACUPUNCTURE VULVODYNIA Meridian points Pudendal nerve Study protocol 

分 类 号：R246.3[医药卫生—针灸推拿学]