Effects of an Osteopathic Manual Therapy Protocol on Heart Rate Variability, Stress, and Anxiety in Young Adults

Official title

Effect of an Osteopathic Intervention Protocol on the Parasympathetic System on Stress and Anxiety in Young Adults: a Randomized Clinical Trial

Overview

Anxiety is characterized by excessive worry and anticipation of future threats, often accompanied by physiological and behavioral manifestations. Anxiety disorders are among the most prevalent mental health conditions worldwide and represent a significant public health concern, particularly among young adults and university students, who frequently experience academic, social, and financial stressors. The aim of this randomized clinical trial is to evaluate the effect of a protocol, consisting of 4 manual techniques, compared to a placebo group, in heart rate variability immediately after the intervention and in anxiety after one week in young adults. The main questions it aims to answer are: Does the osteopathic intervention protocol influence the parasympathetic nervous system? Does the osteopathic intervention protocol influence anxiety and stress? The researchers will compare the osteopathic protocol to a placebo (simulation technique), in order to see if the protocol influences anxiety and stress. Participants will: Prior to the intervention, complete the EADS questionnaire and undergo measurement of heart rate variability; Undergo the protocol or placebo; Immediately after the intervention, they will undergo the measurement of heart rate variability; After one week in the intervention, complete the questionnaire EADS.

Detailed description

Stress and anxiety are highly prevalent mental health conditions, particularly among young adults and university students, and are associated with reduced well-being, impaired academic performance, and autonomic nervous system (ANS) dysregulation. Increased sympathetic activity and reduced parasympathetic activity have been linked to psychological distress, with heart rate variability (HRV) being recognized as a reliable biomarker of autonomic function. Lower HRV parameters, particularly RMSSD and pNN50, have been associated with higher levels of stress and anxiety.

Osteopathic Manipulative Treatment (OMT) may influence autonomic regulation by reducing musculoskeletal tension and promoting parasympathetic activity. The present randomized controlled trial aims to investigate the effects of a manual therapy protocol consisting of Compression of the Fourth Ventricle (CV4), suboccipital decompression, diaphragmatic myofascial release, and sacral rocking on HRV, stress, and anxiety in young adults. These techniques were selected based on their potential influence on vagal activity, respiratory mechanics, and autonomic nervous system regulation.

Participants will be randomly allocated to either an intervention group receiving the manual therapy protocol or a placebo group. The primary outcome is the immediate effect of the intervention on HRV parameters (RMSSD and pNN50), while secondary outcomes include changes in self-reported stress and anxiety symptoms one week after the intervention (EADS-21). The study aims to determine whether a single-session manual therapy protocol can improve autonomic regulation and reduce short-term symptoms of stress and anxiety.

Interventions

• Other Fourth Ventricle Technique
  This technique is performed with the patient in the supine position and lower limbs straight. The technique, according to Sutherland consists of a slight compression performed with the thenar eminence of the Osteopath in the supraoccipital region, precisely on the scale of the patient's occipital bone with compression initiated by the expiration phase of the primary respiratory mechanism and maintaining the compression for 5 min.
• Other Suboccipital Decompression
  The patient is in the supine position, in maximum comfort. The Osteopath is located at the bedside of the table seated. Place both hands inferior to the occiput, and apply pressure to the area located between the occiput and axis, with the distal phalanges of your fingers. Then, apply a force in the anterior and cranial direction. The application of force should be maintained for 5 minutes.
• Other Diaphragm Myofascial Release Technique
  The patient must position himself in the supine position with the lower limbs relaxed, the Osteopath must be at the head of the table and make a manual contact on the lower edge of the last costal arch, in the phase of inspiration the hands of the Osteopath bring laterally and cephalically the diaphragm, following the elevation of the ribs. During expiration, the Osteopath increases contact with the internal costal margin, maintaining resistance. The technique should be performed in a set of 10
• Other Sacral Rock
  The patient is in the prone position. The therapist is positioned laterally at the level of the patient's hip and places the palm of the cephalic hand over the spinous of the first spiny of the sacrum and allows his fingers to rest on the rest of the sacrum. The therapist's caudal hand is placed on the other hand with the thenar and hypothenar zone on the fourth and fifth spinous of the sacrum and the fingers of that same hand towards the patient's head. The therapist instructs the patient to in
• Other Sham Cranial Listening
  The patient is in the supine position and the Osteopath is seated at the head of the table, contacting the patient's skull with both hands as follows: 2nd finger on the greater wings of the sphenoid, 3rd finger on the temporal bone in front of the ears, 4th finger on the temporal bone behind the ears and 5th finger on the occipital bone, while the 1st finger rests on the head, and if possible in contact with each other to act as an external fixed point. To carry out this, the Osteopath only used

Primary outcome measures

• Heart Rate Variability (change in RMSSD and pNN50) [Time frame: Immediately before intervention and immediately after intervention.]
• Change in Anxiety Score [Time frame: 1 week before intervention and 1 week after intervention]
• Change in Stress Score [Time frame: 1 week before intervention and 1 week after intervention]

Eligibility criteria

Inclusion criteria

• age between 18 and 35 years old;
• presence of symptoms/diagnosis of stress and/or anxiety in the last week.

Exclusion criteria

• individuals with cognitive impairments that prevent participation;
• individuals with cardiovascular problems;
• pregnant women;
• those taking medications that affect cardiac function, anxiolytics, and antidepressants;
• caffeine consumption in the last 4 hours;
• alcohol consumption in the previous 24 hours;
• tobacco use in the last 48 hours;
• recent cervical trauma;
• students of osteopathy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Portugal · 1 center

• Escola Superior de Saúde do Porto — Porto

Publications

• Damoun N, Amekran Y, Taiek N, Hangouche AJE. Heart rate variability measurement and influencing factors: Towards the standardization of methodology. Glob Cardiol Sci Pract. 2024 Aug 1;2024(4):e202435. doi: 10.21542/gcsp.2024.35. eCollection 2024 Aug 1. PMID 39351472
• Fornari M, Carnevali L, Sgoifo A. Single Osteopathic Manipulative Therapy Session Dampens Acute Autonomic and Neuroendocrine Responses to Mental Stress in Healthy Male Participants. J Am Osteopath Assoc. 2017 Sep 1;117(9):559-567. doi: 10.7556/jaoa.2017.110. PMID 28846122
• Krassioukov A. Autonomic function following cervical spinal cord injury. Respir Physiol Neurobiol. 2009 Nov 30;169(2):157-64. doi: 10.1016/j.resp.2009.08.003. Epub 2009 Aug 12. PMID 19682607
• Sillevis R, Hansen AW. Could the Suboccipital Release Technique Result in a Generalized Relaxation and Self-Perceived Improvement? A Repeated Measure Study Design. J Clin Med. 2024 Oct 2;13(19):5898. doi: 10.3390/jcm13195898. PMID 39407957
• Cavanagh M, Cope T, Smith D, Tolley I, Orrock P, Vaughan B. The effectiveness of an osteopathic manual technique compared with a breathing exercise on vagal tone as indicated by heart rate variability, a crossover study. J Bodyw Mov Ther. 2024 Apr;38:449-453. doi: 10.1016/j.jbmt.2024.01.003. Epub 2024 Jan 7. PMID 38763591
• Loerup L, Pullon RM, Birks J, Fleming S, Mackillop LH, Gerry S, Watkinson PJ. Trends of blood pressure and heart rate in normal pregnancies: a systematic review and meta-analysis. BMC Med. 2019 Sep 11;17(1):167. doi: 10.1186/s12916-019-1399-1. PMID 31506067
• Liem, T., McPartland, J. M., & Skinner, E. (Eds.). (2012). Cranial osteopathy (2nd ed). Elsevier/Churchill Livingstone.
• Marizeiro, D. F., & Campos, N. G. (sem data). IMMEDIATE EFFECTS OF MIOFASCIAL DIAPHRAGMATIC RELEASE ON LOMBAR COLUMN AND DIAPHRAGMA FUNCTION: A RANDOMIZED PLACEBO- CONTROLLED TRIAL.

Identifiers

NCT: NCT07670806 · OST1-019

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗