Autonomic ImbalanceNCT06477822

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

A study testing Sequence of manual therapy techniques and Simulated manual therapy techniques in people with Autonomic Imbalance, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Autonomic Imbalance
What is being tested?: Sequence of manual therapy techniques and Simulated manual therapy techniques
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteSpain
Study dates: 23 May 2024to 13 Feb 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of informed consent
Aged between 18-65

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Autonomic Imbalance
Being tested: Sequence of manual therapy techniques, Simulated manual therapy techniques
Keywords: autonomic nervous system, manual therapy, heart rate variability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06477822
Study group	Role	What they receive
Sequence of manual therapy techniques	Experimental	Participants receive a manual therapy secuence of techniques Receives: Procedure: Sequence of manual therapy techniques
Simulated manual therapy techniques	Placebo comparator	Participants receive a sequence of simulated manual therapy techniques Receives: Procedure: Simulated manual therapy techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Heart Rate
The investigators will examine the difference between Time 1 and Time 2 and between groups in beats per minute.
Measured: 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
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
Measured: At baseline and immediately post-intervention on Day 1

Secondary outcomes (2)

Change in High Frequency (HF) Band in Heart Rate Variability Index
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
Measured: At baseline and immediately post-intervention on Day 1
Change in Respiratory Rate
The investigators will examine the difference between Time 1 and Time 2 and between groups in breaths per minute.
Measured: At baseline and immediately post-intervention on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202413 Feb 2026

First posted27 Jun 2024
Study start23 May 2024
Primary completion30 Jan 2026
Study completion13 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Autonomic ImbalanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06477822
Sponsor's protocol ID: FIS-2024-01
Status last verified: Jul 2026
First submitted: 11 Jun 2024
Last updated: 21 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

McCorry LK. Physiology of the autonomic nervous system. Am J Pharm Educ. 2007 Aug 15;71(4):78. doi: 10.5688/aj710478.
PubMed 17786266
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.
PubMed 31418887
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.
PubMed 33365319
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.
PubMed 22110948
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.
PubMed 14979884
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.
PubMed 20074444
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.
PubMed 34131526
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.
PubMed 36063265
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.
PubMed 34552462
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.
PubMed 33714500
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.
PubMed 29332747
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.
PubMed 22994907
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.
PubMed 33218540
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.
PubMed 29234380
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.
PubMed 20606239

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Autonomic Imbalance trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06477822
Acronym / sponsor ID: FIS-2024-01
Conditions: Autonomic Imbalance
Keywords: autonomic nervous system, manual therapy, heart rate variability
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Universitat Internacional de CatalunyaUniversity, hospital or other
Study start: 23 May 2024 (actual)
Primary completion: 30 Jan 2026 (actual)
Study completion: 13 Feb 2026 (actual)
First posted: 27 Jun 2024 (actual)
Results: Posted 27 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
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

Arm	Type	Receives
Sequence of manual therapy techniques	Experimental	Procedure: Sequence of manual therapy techniquesParticipants receive a manual therapy secuence of techniques
Simulated manual therapy techniques	Placebo comparator	Procedure: Simulated manual therapy techniquesParticipants receive a sequence of simulated manual therapy techniques

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Provision of informed consent
Aged between 18-65

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sequence of manual therapy techniquesReceive a sequence of manual therapy techniques composed by: suboccipital decompression technique, suboccipital release technique, fourth ventricle compression technique, vagus nerve neurodynamic technique	Procedure or surgery	Sequence of manual therapy techniques
Simulated manual therapy techniquesReceive a sequence of simulated manual therapy techniques composed by four maneuvers without effect on autonomic nervous system	Procedure or surgery	Simulated manual therapy techniques

Primary outcome

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.
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

2 secondary outcomes

Change in High Frequency (HF) Band in Heart Rate Variability Index
Time frame: At baseline and immediately post-intervention on Day 1
Change in Respiratory Rate
Time frame: At baseline and immediately post-intervention on Day 1

Results and safety

Results posted to the registry on 27 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simulated Manual Therapy Techniques	50	48
Sequence of Manual Therapy Techniques	50	48

Primary outcome: Change in Heart Rate

Time frame: At baseline and immediately post-intervention on Day 1. Mean (Standard Deviation). Unit: beat per minute

Measure	Sequence of Manual Therapy Techniques n = 48	Simulated Manual Therapy Techniques n = 48
Value	-2.40 (2.17)	-0.94 (2.41)

Primary outcome: 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. Mean (Standard Deviation). Unit: ms

Measure	Sequence of Manual Therapy Techniques n = 48	Simulated Manual Therapy Techniques n = 48
Value	5.90 (11.61)	1.38 (9.88)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until one week after. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequence of Manual Therapy Techniques	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Simulated Manual Therapy Techniques	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17786266McCorry LK. Physiology of the autonomic nervous system. Am J Pharm Educ. 2007 Aug 15;71(4):78. doi: 10.5688/aj710478.
Background: PubMed 31418887Mogilevski 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.
Background: PubMed 33365319Ingegnoli 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.
Background: PubMed 22110948Martinez-Lavin M. Fibromyalgia: When Distress Becomes (Un)sympathetic Pain. Pain Res Treat. 2012;2012:981565. doi: 10.1155/2012/981565. Epub 2011 Sep 19.
Background: PubMed 14979884Peroutka SJ. Migraine: a chronic sympathetic nervous system disorder. Headache. 2004 Jan;44(1):53-64. doi: 10.1111/j.1526-4610.2004.04011.x.
Background: PubMed 20074444Di 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.
Background: PubMed 34131526Sillevis 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.
Background: PubMed 36063265Gevirtz 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.
Background: PubMed 34552462Carta 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.
Background: PubMed 33714500Silva 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.
Background: PubMed 29332747Amoroso 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.
Background: PubMed 22994907Giles 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

César Fernández de las Peñas study director

Universidad Rey Juan Carlos

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sequence of manual therapy techniques and Simulated manual therapy techniques in people with Autonomic Imbalance, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Heart Rate (time frame: At baseline and immediately post-intervention on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06477822, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.