Osteopathic Bowel Techniques and Their Effects on the Autonomic Nervous System in Healthy Individuals

Healthy Volunteers Clinical Trial

Official title:

Osteopathic Bowel Techniques and Their Effects on the Autonomic Nervous and Pain Pressure Sensitivity: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048823
• Other study ID #: 17249119.2.0000.5515
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2024
• Source: Instituto Docusse de Osteopatia e Terapia Manual
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 30, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

-Health individuals

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Visceral Osteopathic Techniques
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 techniques
Simulated visceral techniques in the region of the gastrointestinal system

Locations

Country	Name	City	State
Brazil	Anne Kastelianne	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Docusse de Osteopatia e Terapia Manual

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability (HRV)	The HRV data will be analyzed using linear methods, analyzed in the time and frequency domains and using geometric indices.	Immediately after intervention
Secondary	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	Immediately after intervention