Assessment of Mediacal Taping Concept Self-applied, in the Treatment of Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Pain NRS (numeric rating scale)
研究概览
简要总结
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.
详细描述
The aim of this study is to assess the analgesic efficacy of self-applied Medical Taping Concept in the treatment of primary dysmenorrhea .
To evaluate this effect, a total of 128 students from the University Miguel Hernández , with the following inclusion criteria, participated in this study: history of menstrual pain, aged between 18 and 39 years who have performed a gynecological check in the last 18 months and who have been diagnosed with any kind of primary dysmenorrhea.
A preliminary survey to identify valid students was made. Thereafter the participants were separated into two different groups (intervention group and placebo group) in order to request the completion of three questionnaires about the characteristics of menstrual pain and other demographic data for the next two menstrual cycles before the intervention. One survey included a graphic scale so the students could mark the start and the end of the symptoms associated with the menstrual cycle.
After that the principal researcher will interviewed with the participants to show them the correct auto-application of the menstrual bandage and placebo. Each students group will receive a triptych with information and pictures to the correct application of the adhesive strips.
Finally, during two new menstrual cycles, the participants will answer the same questionnaires to assess symptoms and menstrual pain while being worn adhesive strips (3 pieces of Kinesio tape - 20 cm x 5 cm Tape Cure ®-, applied to the abdominal and lower back, in the intervention group; 2 pieces of Cross Tape ® 2.5 cm x 2 cm -, in the hip joint, in the placebo group. Participants may do personal hygiene during the days of the menstrual cycle with their adhesives strips placed on oneself.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
- •Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
- •Not have been diagnosed with secondary dysmenorrhea
- •Regular menstrual cycles (cycle typical range of 21 to 35 days)
- •Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
- •Nulliparous
排除标准
- •Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
- •Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
- •Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
- •Women who suffer from diseases diagnosed added
- •Women to which it has undergone a surgical procedure for the treatment
- •Provide skin lesions in the abdominal wall
- •Use or abuse of drugs or alcohol
- •Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO)
结局指标
主要结局
Pain NRS (numeric rating scale)
时间窗: Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Evaluations will be performed before, just after, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment. It will be measured in abdominal area, low back, lower limb and head.
次要结局
- Number of analgesics requiring during menstruation(Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths)
研究者
María Isabel Tomás-Rodríguez, PT
PT, MSC
Universidad Miguel Hernandez de Elche