An interventional study of SBS Decompression Technique and Placebo Technique in Healthy, sponsored by Escola Superior de Tecnologia da Saúde do Porto. Not yet recruiting at 1 site in Portugal. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Escola Superior de Tecnologia da Saúde do Porto · Not applicable, Interventional, and Other
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.
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.
Escola Superior de Tecnologia da Saúde do Porto is the lead sponsor of 37 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The technique was preformed until the investigator felt a relaxation of the structures, with a maximum duration of 5 minutes.
Other: SBS Decompression Technique
The technique was preformed during 2 minutes.
Other: Placebo Technique
The investigator who applied the technique stood on the right side, laterally to the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard, and with a glove on his right hand. Then, he contacted the volunteer's sphenoid wings with his left hand and asked the volunteer to open her mouth, contacting the upper dental arch with the second and third fingers of his right hand. Subsequently, the investigator brought both hands together, followed by an inspiration towards the floor and then a translation towards the ceiling until he felt the structures relax, with a maximum duration of 5 minutes. A second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique.
The investigator was standing, on the right side, laterally to the headboard of the table with feet flat on the floor, at an appropriate level in relation to the headboard of the volunteer's and with a glove on his right hand. Then, he contacted the participant's sphenoid wings with his left hand and asked her to open her mouth. With the second and third fingers of the right hand, he made contact with the upper dental arch. These contacts were maintained for 2 minutes, without moving. A second investigator sat on a chair, placed on the opposite side of the table with the stopwatch in his dominant hand, in order to time the application time of each technique.
Change from baseline in abdominal pain pre and post 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.
Time frame: Two months after first intervention
Change from baseline in number of bowel movements (per day) pre and post 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.
Time frame: Two months after first intervention
Change from baseline in type of feces pre and post 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.
Time frame: Two months after first intervention
Change from baseline in nausea pre and post 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.
Time frame: Two months after first intervention
Change from baseline in presence of abdominal distention pre and post 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.
Time frame: Two months after first intervention
Change from baseline in need to take laxatives pre and post 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.
Time frame: Two months after first intervention
Plan to share: No
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Escola Superior de Tecnologia da Saúde do Porto