Clinical trial NCT06477822: Effect of a Sequence of Specific Manual Therapy Techniques Targeting the Autonomic Nervous System in Healthy Adults
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autonomic Imbalance
Keywords: autonomic nervous system
manual therapy
heart rate variability
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group: receive a manual therapy secuence of techniques focus on the autonomic nervous system Simulated group: receive a sequence of simulated manual therapy techniques
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate
timeFrame: Day 1
measure: Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index
timeFrame: Day 1
Secondary outcomes:
measure: High frequency (HF) band in heart rate variability index
timeFrame: Day 1
measure: Respiratory rate
timeFrame: Day 1
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Day 1
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Universidad Rey Juan Carlos
name: César Fernández de las Peñas
role: STUDY_DIRECTOR
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