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Completed

NCT Number: NCT06477822

Effect of a Sequence of Specific Manual Therapy Techniques Targeting the Autonomic Nervous System in Healthy Adults

The activity of the autonomic nervous system has been shown to influence the appearance of symptoms in some diseases such as rheumatoid arthritis, fibromyalgia, or migraine, among others. In the bibliography we find different authors who, through intervention using manual therapy, have demonstrated its effects on the autonomic nervous system, especially on the increase in parasympathetic activity and reduction in sympathetic activity. A clinical trial is proposed to verify these effects.

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Key information

Conditions

Autonomic Imbalance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

About this study

The aim of the study is to analyse the effects of applying a specific sequence of manual therapy techniques focused on the regulation of the autonomic nervous system. This intervention sequence will be applied in a single intervention. As a result, an immediate increase in parasympathetic activity could occur, measured by different parameters of heart rate variability, heart rate and respiratory rate. If the results confirm the expected effects, this treatment sequence could be used as a therapeutic resource in patients with pathologies whose symptoms may be related to the deregulation of the autonomic nervous system, such as rheumatoid arthritis, migraine or fibromyalgia, among others.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent
  • Aged between 18-65

Exclusion criteria

  • Regular consumtion of alcohol or illegal drugs
  • Consumption of medications whose effect acts on the autonomic nervous system (cholinergic agonists and antagonists, or adrenergic agonists and antagonists)
  • Diagnostic of disease that may affect the activity of the autonomic nervous system or the perception of pain (such as generalized anxiety disorder, fibromyalgia, or chronic fatigue).
  • Pregnancy

Treatment and study plan

Sequence of manual therapy techniques

Procedure

Receive a sequence of manual therapy techniques composed by: suboccipital decompression technique, suboccipital release technique, fourth ventricle compression technique, vagus nerve neurodynamic technique

Simulated manual therapy techniques

Procedure

Receive a sequence of simulated manual therapy techniques composed by four maneuvers without effect on autonomic nervous system

Primary outcomes

  1. Change in Heart Rate

    Time frame: At baseline and immediately post-intervention on Day 1

    The investigators will examine the difference between Time 1 and Time 2 and between groups in beats per minute.

  2. Change in Root Mean Square of the Successive Differences Between Adjacent RR Intervals (RMSSD) in Heart Rate Variability Index

    Time frame: At baseline and immediately post-intervention on Day 1

    The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index

Secondary outcomes

  1. Change in High Frequency (HF) Band in Heart Rate Variability Index

    Time frame: At baseline and immediately post-intervention on Day 1

    The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by high frequency (HF) power of heart rate variability derived from spectral analysis, reflecting parasympathetic nervous system activity, expressed in milliseconds squared (ms²), within the 0.15-0.40 Hz frequency band

  2. Change in Respiratory Rate

    Time frame: At baseline and immediately post-intervention on Day 1

    The investigators will examine the difference between Time 1 and Time 2 and between groups in breaths per minute.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Effect of a Sequence of Specific Manual Therapy Techniques Targeting the Autonomic Nervous System in Healthy Adults: a Single-application Double-blind Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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