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

May 26, 2026 updated by: Pere Ramón Rodríguez Rubio, Universitat Internacional de Catalunya

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Universitat Internacional de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence of manual therapy techniques
Participants receive a manual therapy secuence of techniques
Procedure: Sequence of manual therapy techniques
Receive a sequence of manual therapy techniques composed by: suboccipital decompression technique, suboccipital release technique, fourth ventricle compression technique, vagus nerve neurodynamic technique
Placebo Comparator: Simulated manual therapy techniques
Participants receive a sequence of simulated manual therapy techniques
Procedure: Simulated manual therapy techniques
Receive a sequence of simulated manual therapy techniques composed by four maneuvers without effect on autonomic nervous system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and immediately post-intervention on Day 1
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
At baseline and immediately post-intervention on Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and immediately post-intervention on Day 1
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.
At baseline and immediately post-intervention on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Investigators

  • Study Director: César Fernández de las Peñas, Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

February 13, 2026

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FIS-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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