Healthy VolunteersNCT05048823
Osteopathic Bowel Techniques and Their Effects on the Autonomic Nervous System in Healthy Individuals
A study testing Visceral Osteopathic Techniques and Simulated visceral techniques in people with Healthy Volunteers, run by Instituto Docusse de Osteopatia e Terapia Manual at 1 site in Brazil.
Trial summary
INTRODUCTION: The autonomic nervous system (ANS) is responsible for controlling several visceral functions, including the motility and secretion of the gastrointestinal system (GIS). Alterations in the functioning of the ANS can directly influence the physiological mechanisms of the GIS. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Visceral Osteopathic Techniques and Simulated visceral techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Sep 2021to 30 Oct 2021
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Health individuals
Who cannot join
- Participants with neurological impairment and/or pathologies that interfere with autonomic behavior
- smokers
- diagnosis of pulmonary disease
- Participants with theoretical and/or practical knowledge about the techniques that will be applied in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Bowel Techniques and Their Effects on the Autonomic Nervous and Pain Pressure Sensitivity: Randomized Clinical Trial
INTRODUCTION: The autonomic nervous system (ANS) is responsible for controlling several visceral functions, including the motility and secretion of the gastrointestinal system (GIS). Alterations in the functioning of the ANS can directly influence the physiological mechanisms of the GIS. Due to the importance of the ANS in the control of various body functions, strategies aimed at acting in this system have become extremely important and have been widely used in the literature. Some of the studies involving ANS analysis have shown that osteopathic manipulative treatment is able to promote a reduction in sympathetic ANS activity and an increase in parasympathetic ANS activity in asymptomatic youngsters, however, none of them addressed the GIS, already known to be influenced by autonomic fibers. OBJECTIVE: To evaluate the immediate effects of GIS-directed osteopathic techniques on ANS behavior and pain sensitivity to pressure in young people without symptoms of gastrointestinal disorders. METHODS: The present study is characterized by a randomized, single-blind clinical trial, in which 42 asymptomatic individuals will be recruited, regardless of gender, aged between 18 and 30 years. Volunteers will be randomly distributed into two groups called intervention protocol and placebo protocol. The intervention protocol will be performed by a professional with 10 years of clinical experience in the field of Osteopathy and will perform the techniques of Generalized Discharge of the peritoneum and intestinal wings, Mobilization of the Cecum, technique for the Mesentery Root, Release of the D1-D2 angle, technique for the Sigmoid Colon. The approximate duration of the set of techniques will be 15 minutes with the volunteers positioned supine on a stretcher. The placebo protocol will apply in the same way regarding the positioning and duration of the techniques. The therapist will position the hands in the same regions of the intervention protocol, maintaining superficial contact for 3 minutes in each region, without therapeutic intent. Volunteers will be evaluated for outcomes before and immediately after performing the protocols. The heart rate variability will be measured by capturing the intervals between each beat in ms, using a heart rate monitor and extracting the linear indices in the domain of time, frequency and geometric heart rate variability. The pressure pain threshold will also be measured using a pressure algometer that will be positioned in the vertebral region of T5-L3. Comparisons of variables (indices of HRV and pressure pain threshold) between the intervention protocol group and placebo protocol will be performed using the Student's T test (normal data) or the Mann-Whitney test (non-normal data). All results will be discussed at the 5% significance level.
- Conditions
- Healthy Volunteers
- Being tested
- Visceral Osteopathic Techniques, Simulated visceral techniques
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral Osteopathic TechniquesOther
Generalized Discharge Technique of the Peritoneum and Intestinal Wings, Mobilization of the Cecum, Technique for the Root of the Mesentery, Release of the D1-D2 Angle, Technique for the Sigmoid Colon
Simulated visceral techniquesOther
Simulated visceral techniques in the region of the gastrointestinal system
| Study group | Role | What they receive |
|---|---|---|
| Intervention Protocol | Experimental | Visceral techniques for the gastrointestinal system Receives: Other: Visceral Osteopathic Techniques |
| Placebo Protocol | Sham comparator | simulated visceral techniques in the region of the gastrointestinal system, without therapeutic intent Receives: Other: Simulated visceral techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
The HRV data will be analyzed using linear methods, analyzed in the time and frequency domains and using geometric indices.
Measured: Immediately after intervention
Secondary outcomes (1)
Pressure pain threshold
Pressure pain threshold will be assessed using a mechanical device (algometer), known to quantify pain intensity at a specific point through local pressure. The pain threshold will be considered through the minimum pressure necessary to induce pain in the assessed region. The points evaluated in this study correspond to the thoracic and lumbar levels of T5-L3
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start14 Sep 2021
- Primary completion15 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Docusse de Osteopatia e Terapia Manual
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048823
- Sponsor's protocol ID
- 17249119.2.0000.5515
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared with other researchers when requested
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Bowel Techniques and Their Effects on the Autonomic Nervous and Pain Pressure Sensitivity: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05048823
- Acronym / sponsor ID
- 17249119.2.0000.5515
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Instituto Docusse de Osteopatia e Terapia ManualResearch network
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 17 Sep 2021 (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.
INTRODUCTION: The autonomic nervous system (ANS) is responsible for controlling several visceral functions, including the motility and secretion of the gastrointestinal system (GIS). Alterations in the functioning of the ANS can directly influence the physiological mechanisms of the GIS. Due to the importance of the ANS in the control of various body functions, strategies aimed at acting in this system have become extremely important and have been widely used in the literature. Some of the studies involving ANS analysis have shown that osteopathic manipulative treatment is able to promote a reduction in sympathetic ANS activity and an increase in parasympathetic ANS activity in asymptomatic youngsters, however, none of them addressed the GIS, already known to be influenced by autonomic fibers. OBJECTIVE: To evaluate the immediate effects of GIS-directed osteopathic techniques on ANS behavior and pain sensitivity to pressure in young people without symptoms of gastrointestinal disorders. METHODS: The present study is characterized by a randomized, single-blind clinical trial, in which 42 asymptomatic individuals will be recruited, regardless of gender, aged between 18 and 30 years. Volunteers will be randomly distributed into two groups called intervention protocol and placebo protocol. The intervention protocol will be performed by a professional with 10 years of clinical experience in the field of Osteopathy and will perform the techniques of Generalized Discharge of the peritoneum and intestinal wings, Mobilization of the Cecum, technique for the Mesentery Root, Release of the D1-D2 angle, technique for the Sigmoid Colon. The approximate duration of the set of techniques will be 15 minutes with the volunteers positioned supine on a stretcher. The placebo protocol will apply in the same way regarding the positioning and duration of the techniques. The therapist will position the hands in the same regions of the intervention protocol, maintaining superficial contact for 3 minutes in each region, without therapeutic intent. Volunteers will be evaluated for outcomes before and immediately after performing the protocols. The heart rate variability will be measured by capturing the intervals between each beat in ms, using a heart rate monitor and extracting the linear indices in the domain of time, frequency and geometric heart rate variability. The pressure pain threshold will also be measured using a pressure algometer that will be positioned in the vertebral region of T5-L3. Comparisons of variables (indices of HRV and pressure pain threshold) between the intervention protocol group and placebo protocol will be performed using the Student's T test (normal data) or the Mann-Whitney test (non-normal data). All results will be discussed at the 5% significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Protocol | Experimental | Other: Visceral Osteopathic TechniquesVisceral techniques for the gastrointestinal system |
| Placebo Protocol | Sham comparator | Other: Simulated visceral techniquessimulated visceral techniques in the region of the gastrointestinal system, without therapeutic intent |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Health individuals
Key exclusion criteria (4 listed)
- Participants with neurological impairment and/or pathologies that interfere with autonomic behavior
- smokers
- diagnosis of pulmonary disease
- Participants with theoretical and/or practical knowledge about the techniques that will be applied in the protocol
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 |
|---|---|---|
| Visceral Osteopathic TechniquesGeneralized Discharge Technique of the Peritoneum and Intestinal Wings, Mobilization of the Cecum, Technique for the Root of the Mesentery, Release of the D1-D2 Angle, Technique for the Sigmoid Colon | Other | Intervention Protocol |
| Simulated visceral techniquesSimulated visceral techniques in the region of the gastrointestinal system | Other | Placebo Protocol |
Primary outcome
Heart rate variability (HRV)
Time frame: Immediately after intervention
The HRV data will be analyzed using linear methods, analyzed in the time and frequency domains and using geometric indices.
1 secondary outcome
Pressure pain threshold
Time frame: Immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes. Will be shared with other researchers when requested
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral Osteopathic Techniques and Simulated visceral techniques in people with Healthy Volunteers, run by Instituto Docusse de Osteopatia e Terapia Manual at 1 site in Brazil.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 13 Mar 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.