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

NCT05922189 | Not Yet Recruiting DMC

• 1 other identifier: OST1-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Gastrointestinal symptoms; Menstrual cycle; SBS decompression; Osteopathy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

SBS Decompression Technique

EXPERIMENTAL

The technique was preformed until the investigator felt a relaxation of the structures, with a maximum duration of 5 minutes.

Other: SBS Decompression Technique

Placebo Technique

PLACEBO COMPARATOR

The technique was preformed during 2 minutes.

Other: Placebo Technique

Interventions

SBS Decompression Technique OTHER

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.

SBS Decompression Technique

Placebo Technique OTHER

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.

Placebo Technique

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (7)

• 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.

  PMID: 25851437 BACKGROUND

• Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.

  PMID: 12404243 BACKGROUND

• Dajani EZ, Shahwan TG, Dajani NE. Prostaglandins and brain-gut axis. J Physiol Pharmacol. 2003 Dec;54 Suppl 4:155-64.

  PMID: 15075457 BACKGROUND

• 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.

  PMID: 23423645 BACKGROUND

• 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.

  PMID: 22621660 BACKGROUND

• 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.

  PMID: 15048600 BACKGROUND

• 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.

  PMID: 14612848 BACKGROUND

Study Officials

• Natália MO Campelo, PhD

  Escola Superior de Saúde do Politécnico do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

938674365; ncampelo.estsp.ipp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)