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Starting soon Not applicable

"Physiological Responses to Manual Pressure in Healthy Adults"

NCT07393815 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-03
Last updated
2026-02-06

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

"Manual Pressure Protocol"Manual Therapy Protocols (DLM, light and moderate-pressure massage)Graded Sustained Pressure

"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.

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change in heart rate variability (HRV) index — Baseline and after10 min
    Heart rate variability (HRV) will be recorded continuously using a chest strap. An HRV index (e.g., RMSSD or SDNN) will be calculated for predefined periods (baseline, during and after each pressure condition). The primary outcome will be the change in HRV across pressure levels and between intervention groups.

Trial sites (1)

FacilityCityRegionStatus
Universidad Europea de Madrid Villaviciosa de Odón Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07393815 on ClinicalTrials.gov ↗ ← All trials in Spain