The Effect of the SBS Decompression Technique on Gastrointestinal Symptoms During the Menstrual Cycle

The Effect of SBS Decompression Technique on Gastrointestinal Symptoms During Menstrual Cycle: a Single-blind Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: SBS Decompression Technique; Other: Placebo Technique

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natália MO Campelo, PhD; Phone Number: +351 938674365; Email: ncampelo.estsp.ipp@gmail.com

Study Locations

• Portugal
  • Porto, Portugal, 4200-072
    • Escola Superior da Saúde do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBS Decompression Technique; 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 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.
Placebo Comparator: Placebo Technique; The technique was preformed during 2 minutes.	Other: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Two months after first intervention

Collaborators and Investigators

• Sponsor: Escola Superior de Tecnologia da Saúde do Porto
• Investigators: Principal Investigator: Natália MO Campelo, PhD, Escola Superior de Saúde do Politecnico do Porto

Publications and helpful links

General Publications

• 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.
• Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.
• Dajani EZ, Shahwan TG, Dajani NE. Prostaglandins and brain-gut axis. J Physiol Pharmacol. 2003 Dec;54 Suppl 4:155-64.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Menstrual cycle; Gastrointestinal symptoms; Osteopathy; SBS decompression
• Other Study ID Numbers: OST1-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No