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

NCT06477822 | Recruiting

• 1 other identifier: FIS-2024-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Imbalance

Keywords

autonomic nervous system; manual therapy; heart rate variability

Outcome Measures

Primary Outcomes (2)

• Heart rate

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

  Day 1

• Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index

  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

  Day 1

Secondary Outcomes (3)

• High frequency (HF) band in heart rate variability index

  Day 1

• Respiratory rate

  Day 1

• Incidence of Treatment-Emergent Adverse Events

  Day 1

Study Arms (2)

Sequence of manual therapy techniques

EXPERIMENTAL

Participants receive a manual therapy secuence of techniques

Procedure: Sequence of manual therapy techniques

Simulated manual therapy techniques

PLACEBO COMPARATOR

Participants receive a sequence of simulated manual therapy techniques

Procedure: Simulated manual therapy techniques

Interventions

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

Sequence of manual therapy techniques

Simulated manual therapy techniques PROCEDURE

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

Simulated manual therapy techniques

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Aged between 18-65

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Related Publications (18)

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

  PMID: 17786266 BACKGROUND

• 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.

  PMID: 31418887 BACKGROUND

• 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.

  PMID: 33365319 BACKGROUND

• 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.

  PMID: 22110948 BACKGROUND

• 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.

  PMID: 14979884 BACKGROUND

• 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.

  PMID: 20074444 BACKGROUND

• 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.

  PMID: 34131526 BACKGROUND

• 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.

  PMID: 36063265 BACKGROUND

• 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.

  PMID: 34552462 BACKGROUND

• 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.

  PMID: 33714500 BACKGROUND

• 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.

  PMID: 29332747 BACKGROUND

• 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.

  PMID: 22994907 BACKGROUND

• 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.

  PMID: 33218540 BACKGROUND

• 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.

  PMID: 29234380 BACKGROUND

• 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.

  PMID: 20606239 BACKGROUND

• 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.

  PMID: 26145718 BACKGROUND

• 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.

  PMID: 24054542 BACKGROUND

• 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.

  PMID: 26708360 BACKGROUND

Study Officials

• César Fernández de las Peñas

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Central Study Contacts

Ismael Mohamed Mohamed

CONTACT

+34617692253; imohame@uic.es

César Fernández de las Peñas

CONTACT

cesar.fernandez@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants don't know what intervention are they receiving The outcomes assessor don't know the intervention that the participant is receiving
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 27, 2024
• Study Start: May 23, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)