Physiological Responses to Osteopathic Manipulative Techniques in Healthy Young Adults

NCT05515926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-08-25

No results posted yet for this study

Summary

This study was designed to investigate the effect of selected osteopathic manipulative techniques (OMT) on cardiovascular functions in healthy young men and women.

This work addressed questions regarding physiological responses to OMT in maintaining the cardiovascular homeostasis by (1) measuring changes in the cardiac autonomic nerves activity, (2) measuring changes in cardiovascular parameters such as blood pressure, cardiac contractility, and heart rate, and (3) investigating if changes in the cardiac autonomic nerves activity were related to changes in blood pressure, cardiac contractility, or heart rate.

This controlled not-randomized pilot study with repeated measures was conducted at the Touro University Nevada College of Osteopathic Medicine. Healthy 21-35 years old students and employees volunteered in the study. The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression, occipital-mastoid decompression, and compression of the fourth ventricle, consecutively applied. This study included two control groups; one group received sham manipulations, and the second group did not receive any manipulations and was the non-touch group.

The computerized MP150 BIOPAC System was used for data collection and analysis. The skin electrodes were used for the one-lead ECG and impedance cardiography. Digital data were recorded during the entire experimental protocol. The blood pressure was measured manually before and after the experimental procedure using blood pressure cuff and stethoscope. Cardiovascular responses to OMT were evaluated by using the heart rate variability test (HRV), calculating changes in cardiac contractility, and comparing changes in pre- and post- blood pressure readings.

An analysis of variance (ANOVA) with a Bonferroni post-hoc test was used to evaluate treatment effects. The type I error rate (alpha) was set at 0.05.

Conditions

  • Healthy Young Adults

Interventions

PROCEDURE

Cranial manipulation group, or cranial osteopathic techniques (OMM)

Cranial OMT procedure: Subjects were relaxed and lying on the back for entire time of the research protocol (approximately 30 min). Osteopathic physician performed the osteopathic manipulations using his hands. The physician gently applied a small amount of force to the neck and head to release tissue tension until feeling a softening and warmth of tissues. Subjects experienced a sensation of slight pulling, releasing, or relaxing of the tissue.

PROCEDURE

Sham manipulation

The osteopathic physician placed his hands on the skull of the subject but did not influence cranial motion.

Sponsors & Collaborators

  • Touro University Nevada

    lead OTHER

Principal Investigators

  • Marina Ioudina, MD, PhD, MS · Touro University Nevada

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-04
Primary Completion
2019-08-07
Completion
2019-08-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515926 on ClinicalTrials.gov