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

NCT ID: NCT06477822

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2026-05-28

Brief Summary

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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

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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.

Conditions

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Autonomic Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants don't know what intervention are they receiving The outcomes assessor don't know the intervention that the participant is receiving

Study Groups

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Sequence of manual therapy techniques

Participants receive a manual therapy secuence of techniques

Group Type EXPERIMENTAL

Sequence of manual therapy techniques

Intervention Type 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

Participants receive a sequence of simulated manual therapy techniques

Group Type PLACEBO_COMPARATOR

Simulated manual therapy techniques

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Simulated manual therapy techniques

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Pere Ramón Rodríguez Rubio

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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César Fernández de las Peñas

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ismael Mohamed Mohamed

Role: CONTACT

+34617692253

César Fernández de las Peñas

Role: CONTACT

Facility Contacts

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Pere Ramón Rodríguez Rubio

Role: primary

References

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McCorry LK. Physiology of the autonomic nervous system. Am J Pharm Educ. 2007 Aug 15;71(4):78. doi: 10.5688/aj710478.

Reference Type BACKGROUND
PMID: 17786266 (View on PubMed)

Mogilevski T, Burgell R, Aziz Q, Gibson PR. Review article: the role of the autonomic nervous system in the pathogenesis and therapy of IBD. Aliment Pharmacol Ther. 2019 Oct;50(7):720-737. doi: 10.1111/apt.15433. Epub 2019 Aug 16.

Reference Type BACKGROUND
PMID: 31418887 (View on PubMed)

Ingegnoli F, Buoli M, Antonucci F, Coletto LA, Esposito CM, Caporali R. The Link Between Autonomic Nervous System and Rheumatoid Arthritis: From Bench to Bedside. Front Med (Lausanne). 2020 Dec 7;7:589079. doi: 10.3389/fmed.2020.589079. eCollection 2020.

Reference Type BACKGROUND
PMID: 33365319 (View on PubMed)

Martinez-Lavin M. Fibromyalgia: When Distress Becomes (Un)sympathetic Pain. Pain Res Treat. 2012;2012:981565. doi: 10.1155/2012/981565. Epub 2011 Sep 19.

Reference Type BACKGROUND
PMID: 22110948 (View on PubMed)

Peroutka SJ. Migraine: a chronic sympathetic nervous system disorder. Headache. 2004 Jan;44(1):53-64. doi: 10.1111/j.1526-4610.2004.04011.x.

Reference Type BACKGROUND
PMID: 14979884 (View on PubMed)

Di Franco M, Iannuccelli C, Alessandri C, Paradiso M, Riccieri V, Libri F, Valesini G. Autonomic dysfunction and neuropeptide Y in fibromyalgia. Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S75-8.

Reference Type BACKGROUND
PMID: 20074444 (View on PubMed)

Sillevis R, Trincado G, Shamus E. The immediate effect of a single session of pain neuroscience education on pain and the autonomic nervous system in subjects with persistent pain, a pilot study. PeerJ. 2021 May 31;9:e11543. doi: 10.7717/peerj.11543. eCollection 2021.

Reference Type BACKGROUND
PMID: 34131526 (View on PubMed)

Gevirtz R. The Role of the Autonomic Nervous System in Headache: Biomarkers and Treatment. Curr Pain Headache Rep. 2022 Oct;26(10):767-774. doi: 10.1007/s11916-022-01079-x. Epub 2022 Sep 5.

Reference Type BACKGROUND
PMID: 36063265 (View on PubMed)

Carta G, Seregni A, Casamassima A, Galli M, Geuna S, Pagliaro P, Zago M. Validation and Reliability of a Novel Vagus Nerve Neurodynamic Test and Its Effects on Heart Rate in Healthy Subjects: Little Differences Between Sexes. Front Neurosci. 2021 Sep 6;15:698470. doi: 10.3389/fnins.2021.698470. eCollection 2021.

Reference Type BACKGROUND
PMID: 34552462 (View on PubMed)

Silva BL, Alves de Oliveira L, Costa CM, Guimaraes CQ, Vieira LS, Pernambuco AP. A pilot study of the effects of suboccipital fascial release on heart rate variability in workers in the clothing industry: Randomized clinical trial. J Bodyw Mov Ther. 2021 Jan;25:223-229. doi: 10.1016/j.jbmt.2020.10.020. Epub 2020 Oct 26.

Reference Type BACKGROUND
PMID: 33714500 (View on PubMed)

Amoroso Borges BL, Bortolazzo GL, Neto HP. Effects of spinal manipulation and myofascial techniques on heart rate variability: A systematic review. J Bodyw Mov Ther. 2018 Jan;22(1):203-208. doi: 10.1016/j.jbmt.2017.09.025. Epub 2017 Oct 3.

Reference Type BACKGROUND
PMID: 29332747 (View on PubMed)

Giles PD, Hensel KL, Pacchia CF, Smith ML. Suboccipital decompression enhances heart rate variability indices of cardiac control in healthy subjects. J Altern Complement Med. 2013 Feb;19(2):92-6. doi: 10.1089/acm.2011.0031. Epub 2012 Sep 20.

Reference Type BACKGROUND
PMID: 22994907 (View on PubMed)

Arienti C, Farinola F, Ratti S, Dacco S, Fasulo L. Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):395-401. doi: 10.1016/j.jbmt.2020.07.002. Epub 2020 Jul 31.

Reference Type BACKGROUND
PMID: 33218540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29234380 (View on PubMed)

Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.

Reference Type BACKGROUND
PMID: 20606239 (View on PubMed)

Chaibi A, Saltyte Benth J, Bjorn Russell M. Validation of Placebo in a Manual Therapy Randomized Controlled Trial. Sci Rep. 2015 Jul 6;5:11774. doi: 10.1038/srep11774.

Reference Type BACKGROUND
PMID: 26145718 (View on PubMed)

Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.

Reference Type BACKGROUND
PMID: 24054542 (View on PubMed)

Giles D, Draper N, Neil W. Validity of the Polar V800 heart rate monitor to measure RR intervals at rest. Eur J Appl Physiol. 2016 Mar;116(3):563-71. doi: 10.1007/s00421-015-3303-9. Epub 2015 Dec 26.

Reference Type BACKGROUND
PMID: 26708360 (View on PubMed)

Other Identifiers

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FIS-2024-01

Identifier Type: -

Identifier Source: org_study_id

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