Clinical trial NCT05922189: The Effect of the SBS Decompression Technique on Gastrointestinal Symptoms During the Menstrual Cycle
Official title: The Effect of SBS Decompression Technique on Gastrointestinal Symptoms During Menstrual Cycle: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Gastrointestinal symptoms
Menstrual cycle
SBS decompression
Osteopathy
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female;
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in abdominal pain pre and post intervention
timeFrame: Two months after first intervention
measure: Change from baseline in number of bowel movements (per day) pre and post intervention
timeFrame: Two months after first intervention
measure: Change from baseline in type of feces pre and post intervention
timeFrame: Two months after first intervention
measure: Change from baseline in nausea pre and post intervention
timeFrame: Two months after first intervention
measure: Change from baseline in presence of abdominal distention pre and post intervention
timeFrame: Two months after first intervention
measure: Change from baseline in need to take laxatives pre and post intervention
timeFrame: Two months after first intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior de Saúde do Politécnico do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bharadwaj S, Kulkarni G, Shen B. Menstrual cycle, sex hormones in female inflammatory bowel disease patients with and without surgery. J Dig Dis. 2015 May;16(5):245-55. doi: 10.1111/1751-2980.12247.
citation: Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.
citation: Dajani EZ, Shahwan TG, Dajani NE. Prostaglandins and brain-gut axis. J Physiol Pharmacol. 2003 Dec;54 Suppl 4:155-64.
citation: Lim SM, Nam CM, Kim YN, Lee SA, Kim EH, Hong SP, Kim TI, Kim WH, Cheon JH. The effect of the menstrual cycle on inflammatory bowel disease: a prospective study. Gut Liver. 2013 Jan;7(1):51-7. doi: 10.5009/gnl.2013.7.1.51. Epub 2013 Jan 11.
citation: Bernstein MT, Graff LA, Targownik LE, Downing K, Shafer LA, Rawsthorne P, Bernstein CN, Avery L. Gastrointestinal symptoms before and during menses in women with IBD. Aliment Pharmacol Ther. 2012 Jul;36(2):135-44. doi: 10.1111/j.1365-2036.2012.05155.x. Epub 2012 May 24.
citation: Parlak E, Dagli U, Alkim C, Disibeyaz S, Tunc B, Ulker A, Sahin B. Pattern of gastrointestinal and psychosomatic symptoms across the menstrual cycle in women with inflammatory bowel disease. Turk J Gastroenterol. 2003 Dec;14(4):250-6.
citation: Elhadd TA, Neary R, Abdu TA, Kennedy G, Hill A, McLaren M, Akber M, Belch JJ, Clayton RN. Influence of the hormonal changes during the normal menstrual cycle in healthy young women on soluble adhesion molecules, plasma homocysteine, free radical markers and lipoprotein fractions. Int Angiol. 2003 Sep;22(3):222-8.