HealthyNCT05922189
The Effect of the SBS Decompression Technique on Gastrointestinal Symptoms During the Menstrual Cycle
A study testing SBS Decompression Technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SBS Decompression Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- SBS Decompression Technique, Placebo Technique
- Keywords
- Gastrointestinal symptoms, Menstrual cycle, SBS decompression, Osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBS Decompression TechniqueOther
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 TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SBS Decompression Technique | Experimental | The technique was preformed until the investigator felt a relaxation of the structures, with a maximum duration of 5 minutes. Receives: Other: SBS Decompression Technique |
| Placebo Technique | Placebo comparator | The technique was preformed during 2 minutes. Receives: Other: Placebo Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two months after first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Sep 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Saúde do Politécnico do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922189
- Sponsor's protocol ID
- OST1-006
- Status last verified
- Apr 2024
- First submitted
- 19 Jun 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25851437Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.
PubMed 12404243Dajani EZ, Shahwan TG, Dajani NE. Prostaglandins and brain-gut axis. J Physiol Pharmacol. 2003 Dec;54 Suppl 4:155-64.
PubMed 15075457Lim 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.
PubMed 23423645Bernstein 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.
PubMed 22621660Parlak 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.
PubMed 15048600Elhadd 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.
PubMed 14612848
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SBS Decompression Technique on Gastrointestinal Symptoms During Menstrual Cycle: a Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05922189
- Acronym / sponsor ID
- OST1-006
- Conditions
- Healthy
- Keywords
- Gastrointestinal symptoms, Menstrual cycle, SBS decompression, Osteopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBS Decompression Technique | Experimental | Other: SBS Decompression TechniqueThe technique was preformed until the investigator felt a relaxation of the structures, with a maximum duration of 5 minutes. |
| Placebo Technique | Placebo comparator | Other: Placebo TechniqueThe technique was preformed during 2 minutes. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBS Decompression TechniqueThe 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. | Other | SBS Decompression Technique |
| Placebo TechniqueThe 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. | Other | Placebo Technique |
Primary outcome
Change from baseline in abdominal pain pre and post intervention
Time frame: Two months after first 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.
Change from baseline in number of bowel movements (per day) pre and post intervention
Time frame: Two months after first 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.
Change from baseline in type of feces pre and post intervention
Time frame: Two months after first 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.
Change from baseline in nausea pre and post intervention
Time frame: Two months after first 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.
Change from baseline in presence of abdominal distention pre and post intervention
Time frame: Two months after first 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.
Change from baseline in need to take laxatives pre and post intervention
Time frame: Two months after first 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 25851437Bharadwaj 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.
- Background: PubMed 12404243Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.
- Background: PubMed 15075457Dajani EZ, Shahwan TG, Dajani NE. Prostaglandins and brain-gut axis. J Physiol Pharmacol. 2003 Dec;54 Suppl 4:155-64.
- Background: PubMed 23423645Lim 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.
- Background: PubMed 22621660Bernstein 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.
- Background: PubMed 15048600Parlak 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.
- Background: PubMed 14612848Elhadd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natália MO Campelo, PhD principal investigator
Escola Superior de Saúde do Politécnico do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBS Decompression Technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (938674365 ext. +351, ncampelo.estsp.ipp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in abdominal pain pre and post intervention (time frame: Two months after first intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922189, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.