Physiological Responses to Osteopathic Manipulative Techniques in Healthy Young Adults

NCT05515926 | Completed

• 1 other identifier: TUN IRB4-10-13A
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Osteopathic manipulation; Autonomic; Cardiovascular

Outcome Measures

Primary Outcomes (5)

• Change in heart rate variability immediately after manipulation

  The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.

  Baseline and 2 minutes after manipulation

• Change in heart rate variability 10 min after manipulation

  The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.

  Baseline and 10 minutes after manipulation

• Change in cardiac impedance immediately after manipulation

  Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.

  Baseline and 2 minutes after manipulation

• Change in cardiac impedance 10 minutes after manipulation

  Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.

  Baseline and 10 minutes after manipulation

• Change in blood pressure 10 minutes after manipulation

  Blood pressure was measured by sphygmomanometer. Changes in blood pressure would indicate the effect of manipulation on vascular sympathetic tone.

  Baseline and 10 minutes after manipulation

Study Arms (3)

Cranial OMT

EXPERIMENTAL

The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression (OAD), occipital-mastoid decompression (OMD), and compression of the fourth ventricle (CV4), consecutively applied.

Procedure: Cranial manipulation group, or cranial osteopathic techniques (OMM)

Sham manipulation

SHAM COMPARATOR

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

Procedure: Sham manipulation

Non touch group

NO INTERVENTION

The control group whose members did not receive any manipulations.

Interventions

Cranial manipulation group, or cranial osteopathic techniques (OMM) PROCEDURE

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.

Also known as: Cranial osteopathic manipulations, cranial osteopathic techniques, cranial OMT procedure

Cranial OMT

Sham manipulation PROCEDURE

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

Also known as: Sham

Sham manipulation

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults

You may not qualify if:

• Clinical diagnosis of chronic cardiovascular diseases
• Clinical diagnosis of pulmonary diseases
• Clinical diagnosis of renal diseases
• Clinical diagnosis of diabetes mellitus
• Clinical diagnosis of endocrine disorders affecting the cardiovascular system
• Clinical diagnosis of pregnancy
• Clinical diagnosis of musculoskeletal conditions that can affect the use of the cranial OMTs
• Any acute illness that necessitates consulting a healthcare provider

Sponsors & Collaborators

• Touro University Nevada: lead

Related Publications (5)

• Zurowska A, Malak R, Kolcz-Trzesicka A, Samborski W, Paprocka-Borowicz M. Compression of the Fourth Ventricle Using a Craniosacral Osteopathic Technique: A Systematic Review of the Clinical Evidence. Evid Based Complement Alternat Med. 2017;2017:2974962. doi: 10.1155/2017/2974962. Epub 2017 Oct 18.

  PMID: 29234380 BACKGROUND

• Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.

  PMID: 26199632 BACKGROUND

• Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.

  PMID: 21147421 BACKGROUND

• Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.

  PMID: 15750368 BACKGROUND

• Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.

  PMID: 22182954 BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Marina Ioudina, MD, PhD, MS

  Touro University Nevada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 25, 2022
• Study Start: October 4, 2013
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication
• Access Criteria: By direct contact with study authors