The Effect of SBS Decompression Technique on Gastrointestinal Symptoms During Menstrual Cycle: a Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in nausea pre and post intervention
研究概览
简要总结
Determining the effects of a single application of the sphenobasilar synchondrosis (SBS) decompression technique, on gastrointestinal symptoms during the menstrual cycle is an area that lacks of evidence and proper studies. Therefore the investigators consider this an interesting topic to study.
详细描述
The menstrual cycle is determined by cyclic changes in hormones levels, whose secretion is regulated by the feedback system of the hypothalamic-pituitary-gonadal axis and lasts approximately 28 days. These hormones have direct effects on organs as well as on the peripheral and central nervous systems (CNS), acting alone or in combination to influence both bowel function and gastrointestinal symptoms.
Premenstrually, uterine prostaglandin production can mediate an inflammatory response characterized by pain, and during menstruation, abnormally high levels of prostaglandins in menstrual fluid can induce abnormal uterine contractions. In the intestine, prostaglandins can cause smooth muscle contractions, as well as reduced absorption and induced secretion of electrolytes in the small intestine, increasing gastrointestinal symptomatology.
A study concluded that sphenobasilar synchondrosis (SBS) dysfunctions may be directly related to changes in the endocrine and hormonal system, due to the location of the pituitary gland (endocrine gland responsible for the release mainly of follicle stimulating hormone (FSH) and lutein hormone (LH)). Thus, there is a relationship between the SBS decompression technique and gastrointestinal symptoms during the menstrual cycle.
However this theme lacks of scientific evidence, therefore the investigators intend to collaborate to increase knowledge in this area, determining the effects of the SBS decompression technique, on gastrointestinal symptoms during the menstrual cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages between 18 and 25 years old;
- •Gastrointestinal symptoms in the week before, during, or after menstrual period;
- •Regular menstrual cycle ;
- •Taking an oral hormonal pill.
排除标准
- •People who are undergoing / who have already undergone hormonal therapies;
- •Pregnancy;
- •Orthodontic braces or dental plate;
- •Temporomandibular joint dysfunction or other dysfunction that prevents the opening of the mouth;
- •Present or have presented in the last 3 months any of these conditions: high blood pressure, tumors, acute intracranial bleeding/haemorrhage, increased intracranial pressure, acute skull fracture, convulsive states;
- •Started/changed/stopped taking a hormonal contraceptive method in the last 3 months;
- •BMI greater than 30;
- •Students of osteopathy or being subjected to an osteopathic treatment during the study.
研究组 & 干预措施
SBS Decompression Technique
The technique was preformed until the investigator felt a relaxation of the structures, with a maximum duration of 5 minutes.
干预措施: SBS Decompression Technique (Other)
Placebo Technique
The technique was preformed during 2 minutes.
干预措施: Placebo Technique (Other)
结局指标
主要结局
Change from baseline in nausea pre and post intervention
时间窗: Two months after first intervention
The participants were submited to constant evaluation through the diary that they had to fill in daily, during two menstrual cycles, which corresponds to a total of about 2 months. At the end of completing each cycle, the corresponding diary was sent to the researchers, so that they could record the information.
Change from baseline in abdominal pain pre and post intervention
时间窗: Two months after first intervention
The participants were submited to constant evaluation through the diary that they had to fill in daily, during two menstrual cycles, which corresponds to a total of about 2 months. At the end of completing each cycle, the corresponding diary was sent to the researchers, so that they could record the information.
Change from baseline in need to take laxatives pre and post intervention
时间窗: Two months after first intervention
The participants were submited to constant evaluation through the diary that they had to fill in daily, during two menstrual cycles, which corresponds to a total of about 2 months. At the end of completing each cycle, the corresponding diary was sent to the researchers, so that they could record the information.
Change from baseline in presence of abdominal distention pre and post intervention
时间窗: Two months after first intervention
The participants were submited to constant evaluation through the diary that they had to fill in daily, during two menstrual cycles, which corresponds to a total of about 2 months. At the end of completing each cycle, the corresponding diary was sent to the researchers, so that they could record the information.
Change from baseline in number of bowel movements (per day) pre and post intervention
时间窗: Two months after first intervention
The participants were submited to constant evaluation through the diary that they had to fill in daily, during two menstrual cycles, which corresponds to a total of about 2 months. At the end of completing each cycle, the corresponding diary was sent to the researchers, so that they could record the information.
Change from baseline in type of feces pre and post intervention
时间窗: Two months after first intervention
The participants were submited to constant evaluation through the diary that they had to fill in daily, during two menstrual cycles, which corresponds to a total of about 2 months. At the end of completing each cycle, the corresponding diary was sent to the researchers, so that they could record the information.
次要结局
未报告次要终点
研究者
Natália Maria Oliveira Campelo
Professor
Escola Superior de Tecnologia da Saúde do Porto