Health TrialsbyHealthPanel

"Physiological Responses to Manual Pressure in Healthy Adults"

ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Europea de Madrid

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • "Manual Pressure Protocol"

    Other intervention

    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)

    Other intervention

    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

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Experimental: Sustained PressureExperimental treatment 1 intervention
Group B: Experimental: Longitudinal KneadingExperimental treatment 1 intervention
Group C: Experimental: Manual Therapy ProtocolsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in heart rate variability (HRV) index

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.

Time frame
Baseline and after10 min

Secondary outcomes

1

Change in capillary cortisol level

Capillary blood cortisol measured by ELISA; changes relative to baseline will be compared across pressure levels and groups.

Time frame
Baseline and after10 min
2

Change in mechanical pain threshold (von Frey)

Mechanical pain thresholds assessed with von Frey filaments at predefined sites (upper trapezius and forearm); changes across pressure levels and groups.

Time frame
Baseline and after10 min
3

Change in blood pressure

Systolic and diastolic blood pressure measured with a manual sphygmomanometer.

Time frame
Baseline and after10 min
4

Change in skin temperature

Continuous recording throughout the session.

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Europea de Madrid

Lead sponsor

Source ClinicalTrials.gov

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