"Physiological Responses to Manual Pressure in Healthy Adults"

Официальное название

Physiological Responses to Graded Manual Pressure in Healthy Adults: a Randomized Experimental Study on Autonomic, Hormonal, Sensory and Vascular Outcomes

Обзор

This randomized experimental study will investigate how different intensities and application patterns of manual pressure applied to the upper trapezius muscle affect physiological responses in healthy adults. Participants will be randomly assigned to one of three groups: (A) graded sustained pressure at a single point over the upper trapezius, (B) graded longitudinal kneading over a defined area of the upper trapezius, or (C) three standardized manual therapy protocols with increasing pressure (manual lymphatic drainage, light-pressure massage and moderate-pressure massage). In groups A and B, five individualized pressure levels (0, 25, 50, 75 and 95% of each participant's pressure pain threshold) will be delivered for 2 minutes each in a single session. In group C, each participant will receive the three manual therapy protocols in separate randomized sessions. Autonomic (heart rate and heart rate variability), hormonal (capillary cortisol and VEGF in group C), sensory (mechanical pain thresholds), hemodynamic (blood pressure) and, in group C, vascular (left common carotid artery ultrasound) responses will be recorded before and after the interventions. The study will provide dose-response and mechanistic information to inform safer and more individualized manual therapy protocols.

Подробное описание

This prospective randomized experimental study will be conducted in healthy adults to characterize acute physiological responses to different intensities and patterns of manual pressure applied to the upper trapezius muscle. Participants will be randomly allocated to one of three experimental groups:

* Group A - Graded sustained pressure: a personalized pressure scale is defined based on the individual pressure pain threshold (PPT) measured with an algometer. Five pressure levels are set at 0% (contact without pressure), 25%, 50%, 75% and 95% of PPT, and applied as sustained pressure at a single point over the upper trapezius. * Group B - Graded longitudinal kneading: the same personalized pressure scale (0, 25, 50, 75 and 95% of PPT) is applied as longitudinal kneading distributed over a predefined area of the upper trapezius. * Group C - Manual therapy protocols: each participant receives three standardized manual therapy protocols in separate sessions, with randomized order: manual lymphatic drainage (approx. 40 minutes at \~40 mmHg), light-pressure massage (0.5-0.8 N/cm², 20-30 minutes) and moderate-pressure massage (2-3 N/cm², 20 minutes), all targeting the upper trapezius and related regions.

In groups A and B, the five pressure levels are each applied for 2 minutes in a single experimental session, in randomized order, with rest periods of at least 5 minutes between levels (extended if needed until heart rate returns within ±10% of baseline). In group C, each manual therapy protocol is applied in a separate session with at least one day between sessions. In all groups, heart rate and heart rate variability are recorded continuously with a chest strap, and skin temperature and skin conductance are continuously monitored with surface sensors. Blood pressure, mechanical pain thresholds (von Frey filaments at predefined trapezius and forearm sites), and capillary blood samples for cortisol are obtained at baseline and immediately after each pressure level or massage protocol. In group C, VEGF is also measured in capillary blood.

In group C only, duplex ultrasound of the left common carotid artery is performed under standardized conditions (semi-recumbent position, head rotated 45° to the right) before the manual therapy protocol and 10 minutes after its completion, to assess luminal diameter, intima-media thickness and peak systolic velocity. All pressure applications in all groups are monitored with a pressure-sensing system (Loadpad) placed on the therapist's hand.

A separate visit includes whole-body dual-energy X-ray absorptiometry (DEXA) to characterize body composition (total and segmental lean mass and fat mass). The main outcome is a heart rate variability index (e.g., RMSSD), while hormonal (cortisol, VEGF in group C), sensory (pain thresholds), hemodynamic (blood pressure) and vascular (carotid ultrasound in group C) measures are considered secondary outcomes. The study is powered assuming a large effect size on HRV based on previous massage research, with a planned sample size of 30 participants per group (N = 90).

Вмешательства

• Другое "Manual Pressure Protocol"
  Manual pressure is applied over the upper trapezius muscle using five individualized pressure levels (0, 25, 50, 75 and 90% of the pressure pain threshold). Each level is applied for 2 minutes in a single experimental session, with randomized order and rest periods between applications. In the Sustained Pressure arm, pressure is maintained at a single point. In the Longitudinal Kneading arm, the same pressure levels are distributed along a predefined area using a kneading technique.
• Другое Manual Therapy Protocols (DLM, light and moderate-pressure massage)
  Three standardized manual therapy protocols targeting the upper trapezius and related regions are applied in separate sessions with at least one day between them and randomized order: (1) manual lymphatic drainage (approx. 40 minutes at \~40 mmHg), (2) light-pressure massage (0.5-0.8 N/cm², 20-30 minutes) and (3) moderate-pressure massage (2-3 N/cm², 20 minutes). Pressure is monitored continuously with a hand-worn pressure sensor.
• Другое Graded Sustained Pressure
  Manual pressure applied over the upper trapezius using five individualized pressure levels (0, 25, 50, 75 and 95% of the pressure pain threshold) delivered as sustained pressure at a single point, 2 minutes per level in a single session, with randomized order and rest periods between applications.

Первичные конечные точки

• Change in heart rate variability (HRV) index [Срок оценки: Baseline and after10 min]

Вторичные конечные точки (10)

• Change in capillary cortisol level [Срок оценки: Baseline and after10 min]
• Change in mechanical pain threshold (von Frey) [Срок оценки: Baseline and after10 min]
• Change in blood pressure [Срок оценки: Baseline and after10 min]
• Change in skin temperature [Срок оценки: Periprocedural]
• Change in skin conductance [Срок оценки: Periprocedural]
• Change in common carotid artery diameter [Срок оценки: Baseline and after10 min]
• Change in common carotid artery intima-media thickness (IMT) [Срок оценки: Baseline and after10 min]
• Change in common carotid artery peak systolic velocity (PSV) [Срок оценки: Baseline and after10 min]
• Body composition (DEXA) [Срок оценки: Baseline]
• Change in capillary VEGF level [Срок оценки: Baseline and after10 min]

Критерии участия

Критерии включения

• Age 18-65 years.
• Healthy volunteers without diagnosed cardiovascular, neurological or severe musculoskeletal disorders.
• No significant pain or pathology in the cervical, shoulder or upper back region that would interfere with pressure application.
• Ability to understand the study procedures and to provide written informed consent.
• Availability to attend the experimental session and the DEXA visit.

Критерии исключения

• History of major cardiovascular disease (e.g., ischemic heart disease, heart failure, clinically significant arrhythmias, uncontrolled hypertension, stroke or transient ischemic attack).
• Neurological disorders affecting pain perception or autonomic function.
• Acute or chronic musculoskeletal conditions in the cervical or shoulder region that contraindicate manual pressure on the upper trapezius.
• Coagulation disorders or high-dose anticoagulant/antiplatelet therapy that increases bleeding risk.
• Dermatologic conditions or skin lesions at sensor placement or pressure application sites.
• Pregnancy or suspected pregnancy (due to DEXA scan).
• Regular use of medications with a major impact on autonomic or cardiovascular responses (e.g., beta-blockers, antiarrhythmics) that cannot be paused according to medical judgement.
• Substance abuse or acute alcohol/drug intake in the 24 hours prior to the experimental session.
• Any other condition that, in the opinion of the investigators, may compromise safety or compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Испания · 1 центр

• Universidad Europea de Madrid — Villaviciosa de Odón

Публикации

• Unalmis Y, Muniroglu S. Efficacy of fascial manipulation in musculoskeletal pain management: A decade in review (2015-2025). J Bodyw Mov Ther. 2026 Jun;46:147-156. doi: 10.1016/j.jbmt.2025.11.011. Epub 2025 Nov 8. PMID 41927169
• Roura S, Alvarez G, Sola I, Cerritelli F. Do manual therapies have a specific autonomic effect? An overview of systematic reviews. PLoS One. 2021 Dec 2;16(12):e0260642. doi: 10.1371/journal.pone.0260642. eCollection 2021. PMID 34855830
• Picchiottino M, Leboeuf-Yde C, Gagey O, Hallman DM. The acute effects of joint manipulative techniques on markers of autonomic nervous system activity: a systematic review and meta-analysis of randomized sham-controlled trials. Chiropr Man Therap. 2019 Mar 12;27:17. doi: 10.1186/s12998-019-0235-1. eCollection 2019. PMID 30911373
• Mehrara BJ, Radtke AJ, Randolph GJ, Wachter BT, Greenwel P, Rovira II, Galis ZS, Muratoglu SC. The emerging importance of lymphatics in health and disease: an NIH workshop report. J Clin Invest. 2023 Sep 1;133(17):e171582. doi: 10.1172/JCI171582. PMID 37655664
• Pérez García R, Ruiz Miñarro R, Robledo Do Nascimento Y (2018) Efectos del DLM en la respuesta inmunitaria específica. Congreso Internacional de Fisioterapia 1:1
• Minguez-Esteban I, De la Cueva-Reguera M, Abuin-Porras V, Romero-Morales C, Almazan-Polo J, Bravo-Aguilar M. Acute sonographic changes in common carotid artery after NESA neuromodulation intervention in healthy adults: a randomized controlled clinical trial. Front Neurosci. 2025 Apr 28;19:1526236. doi: 10.3389/fnins.2025.1526236. eCollection 2025. PMID 40356697
• Lima CR, Martins DF, Reed WR. Physiological Responses Induced by Manual Therapy in Animal Models: A Scoping Review. Front Neurosci. 2020 May 8;14:430. doi: 10.3389/fnins.2020.00430. eCollection 2020. PMID 32457570
• Liao S, Padera TP. Lymphatic function and immune regulation in health and disease. Lymphat Res Biol. 2013 Sep;11(3):136-43. doi: 10.1089/lrb.2013.0012. Epub 2013 Sep 11. No abstract available. PMID 24024577

Идентификаторы

NCT: NCT07393815 · VALIRAT 1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗