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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence of manual therapy techniques | Experimental | Participants receive a manual therapy secuence of techniques |
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| Simulated manual therapy techniques | Placebo Comparator | Participants receive a sequence of simulated manual therapy techniques |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline and immediately post-intervention on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| César Fernández de las Peñas | Universidad Rey Juan Carlos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17786266 | Background | McCorry LK. Physiology of the autonomic nervous system. Am J Pharm Educ. 2007 Aug 15;71(4):78. doi: 10.5688/aj710478. | |
| 31418887 | 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. |
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Two participants were excluded because they did not meet the inclusion criteria. One of them consumed alcohol, and the other, an energy drink.
One hundred and two participants were assessed for elegibility. Six participants were excluded: two did not meet the inclusion criteria and four did not complete the intervention protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simulated Manual Therapy Techniques | Participants receive a sequence of simulated manual therapy techniques |
| FG001 | Sequence of Manual Therapy Techniques | Participants receive a manual therapy secuence of techniques |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2026 | May 26, 2026 |
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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
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The participants don't know what intervention are they receiving The outcomes assessor don't know the intervention that the participant is receiving
| Simulated manual therapy techniques | Procedure | Receive a sequence of simulated manual therapy techniques composed by four maneuvers without effect on autonomic nervous system |
|
| Change in Respiratory Rate | 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 |
| 33365319 | 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. |
| 22110948 | 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. |
| 14979884 | 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. |
| 20074444 | 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. |
| 34131526 | 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. |
| 36063265 | 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. |
| 34552462 | 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. |
| 33714500 | 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. |
| 29332747 | 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. |
| 22994907 | 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. |
| 33218540 | 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. |
| 29234380 | 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. |
| 20606239 | 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. |
| 26145718 | 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. |
| 24054542 | 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. |
| 26708360 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence of Manual Therapy Techniques | Participants receive a manual therapy secuence of techniques, consisting in 4 techniques: fourth ventricle compression , suboccipital decompression , suboccipital inhibition , and vagus nerve neurodinamic |
| BG001 | Simulated Manual Therapy Techniques | Participants receive a sequence of simulated manual therapy techniques, consisting in 4 techniques: fourth ventricle compression simulation, suboccipital decompression simulation, suboccipital inhibition simulation, and vagus nerve neurodinamic simulation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Gender of the participant | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| height | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Heart Rate | The investigators will examine the difference between Time 1 and Time 2 and between groups in beats per minute. | Posted | Mean | Standard Deviation | beat per minute | At baseline and immediately post-intervention on Day 1 |
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| Primary | 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 | Posted | Mean | Standard Deviation | ms | At baseline and immediately post-intervention on Day 1 |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ms | At baseline and immediately post-intervention on Day 1 |
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| Secondary | Change in Respiratory Rate | The investigators will examine the difference between Time 1 and Time 2 and between groups in breaths per minute. | Posted | Mean | Standard Deviation | breaths per minute | At baseline and immediately post-intervention on Day 1 |
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From enrollment until one week after
An adverse event was defined as any undesirable sign, symptom, or medical condition temporally associated with participation in the study procedures, regardless of causality. This included symptoms such as dizziness, discomfort, palpitations, fatigue, or any other unexpected symptom occurring during or after the intervention. Adverse events were assessed through participant self-report and investigator observation from the enrollment until one week after the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequence of Manual Therapy Techniques | Participants receive a manual therapy secuence of techniques | 0 | 48 | 0 | 48 | 0 | 48 |
| EG001 | Simulated Manual Therapy Techniques | Participants receive a sequence of simulated manual therapy techniques | 0 | 48 | 0 | 48 | 0 | 48 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ismael Mohamed | UIC | +34617692253 | imohame@uic.es |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2026 | May 26, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 25, 2026 | May 26, 2026 | ICF_002.pdf |
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