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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Visceral Osteopathic Techniques; Other: Simulated visceral techniques

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Presidente Prudente, São Paulo, Brazil
      • Anne Kastelianne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Protocol; Visceral techniques for the gastrointestinal system	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
Sham Comparator: Placebo Protocol; simulated visceral techniques in the region of the gastrointestinal system, without therapeutic intent	Other: Simulated visceral techniques; Simulated visceral techniques in the region of the gastrointestinal system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Docusse de Osteopatia e Terapia Manual

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Other Study ID Numbers: 17249119.2.0000.5515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be shared with other researchers when requested
• IPD Sharing Time Frame: After one year from publication
• IPD Sharing Access Criteria: To request the data, please contact nupi@idot.com.br
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No