"Physiological Responses to Manual Pressure in Healthy Adults"

NCT07393815 | Not Yet Recruiting

• 1 other identifier: VALIRAT 1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Autonomic Nervous System; Manual Therapy; Pain

Outcome Measures

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.

  Baseline and after10 min

Secondary Outcomes (10)

• Change in capillary cortisol level

  Baseline and after10 min

• Change in mechanical pain threshold (von Frey)

  Baseline and after10 min

• Change in blood pressure

  Baseline and after10 min

• Change in skin temperature

  Periprocedural

• Change in skin conductance

  Periprocedural

Study Arms (3)

Experimental: Sustained Pressure

EXPERIMENTAL

Participants receive a graded manual pressure protocol applied as sustained pressure at a single point over the upper trapezius muscle (0, 25, 50, 75 and 90% of individual PPT, 2 minutes each level, randomized order).

Other: Graded Sustained Pressure

Experimental: Longitudinal Kneading

EXPERIMENTAL

Participants receive the same graded pressure protocol applied as longitudinal kneading over a defined area of the upper trapezius muscle (0, 25, 50, 75 and 90% of individual PPT, 2 minutes each level, randomized order).

Other: "Manual Pressure Protocol"

Experimental: Manual Therapy Protocols

EXPERIMENTAL

Participants receive three standardized manual therapy protocols with increasing pressure in three separate sessions, with randomized order: (1) manual lymphatic drainage (\~40 mmHg, approximately 40 minutes), (2) light-pressure massage (0.5-0.8 N/cm², 20-30 minutes) and (3) moderate-pressure massage (2-3 N/cm², 20 minutes), targeting the upper trapezius and related regions.

Other: Manual Therapy Protocols (DLM, light and moderate-pressure massage)

Interventions

"Manual Pressure Protocol" OTHER

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.

Experimental: Longitudinal Kneading

Graded Sustained Pressure OTHER

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.

Experimental: Sustained Pressure

Manual Therapy Protocols (DLM, light and moderate-pressure massage) OTHER

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.

Experimental: Manual Therapy Protocols

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Spain

Location

Related Publications (11)

• Unalmis Y, Muniroglu S (2026). Efficacy of fascial manipulation in musculoskeletal pain management: a decade in review (2015-2025). J. Bodyw. Mov. Ther. 46:147-156.

  BACKGROUND

• Roura S, Álvarez G, Solà I, Cerritelli F (2021) Do manual therapies have a specific autonomic effect? An overview of systematic reviews. PLoS ONE 16(12): e0260642

  BACKGROUND

• Picchiottino M, Leboeuf-Yde C, Gagey O, Hallman DM. (2019) 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. 27:17.

  BACKGROUND

• Petrova TV, Koh GY (2023). The Emerging Importance of Lymphatics in Health and Disease. J. Clin. Invest. 133(12):e171582

  BACKGROUND

• 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

  BACKGROUND

• Mínguez-Esteban, I., De la Cueva-Reguera, M., Abuín-Porras, V., Romero-Morales, C., Almazán-Polo, J., & Bravo-Aguilar, M. (2025). Acute sonographic changes in common carotid artery after NESA neuromodulation intervention in healthy adults: A randomized controlled clinical trial. Frontiers in Neuroscience, 19, 1526236

  BACKGROUND

• • Lima CR, Fernandes Martins D, Reed WR (2020). Physiological responses induced by manual therapy in animal models: a scoping review. Front. Neurosci. 14:430

  BACKGROUND

• Huggenberger R, Detmar M (2013). Lymphatic Function and Immune Regulation in Health and Disease. Lymph. Res. Biol. 11(1):1-17

  BACKGROUND

• Diego MA, Field T (2009). Moderate pressure massage elicits a parasympathetic nervous system response. Int. J. Neurosci. 119:630-638

  BACKGROUND

• Amoroso Borges BL, Bortolazzo GL, Neto HP. (2018) Effects of spinal manipulation and myofascial techniques on heart rate variability: A systematic review. J Bodyw Mov Ther. 22:203-208

  BACKGROUND

• Alnefaie HA, Alserahi YS, Kattan MI, Alsaedi SS, Shafei SI, Alotaibi AA, Alfahemy MM, Alqethmi FS, Alkhattabi AH (2025). Physiotherapy in the management of musculoskeletal disorders: a systematic review. The review of diabetic studies 21:102-114.

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Light

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Central Study Contacts

Elena Velarde Dr, Byology Doctor

CONTACT

(34) 0912115268; elena.velarde@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

ES (1)