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

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Escola Superior de Tecnologia da Saúde do Porto

Status

Not yet enrolling

Conditions

Healthy

Treatments

Other: Placebo Technique
Other: SBS Decompression Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT05922189
OST1-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

SBS Decompression Technique
Experimental group
Description:
The technique was preformed until the investigator felt a relaxation of the structures, with a maximum duration of 5 minutes.
Treatment:
Other: SBS Decompression Technique
Placebo Technique
Placebo Comparator group
Description:
The technique was preformed during 2 minutes.
Treatment:
Other: Placebo Technique

Trial contacts and locations

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Central trial contact

Natália MO Campelo, PhD

Data sourced from clinicaltrials.gov

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