NCT07433543

Brief Summary

Foam rolling (FR) is a technique involving the application of external pressure to muscles and connective tissues using different devices (e.g. foam rollers, massage rollers, balls, etc.) , with the aim of reducing muscle tension, soreness, and stiffness, and improving circulation, and flexibility. Emerging evidence suggests that FR may also enhance tissue perfusion and blood flow and could induce a relaxation response, potentially modulating autonomic balance toward increased parasympathetic activity. The cervical region is of particular interest due to the presence of clinically relevant vascular structures, such as the carotid arteries, whose mechanical stimulation may elicit cardiovascular responses. Accordingly, the present study was designed to investigate the acute effects of cervical foam rolling on blood pressure, while simultaneously examining tissue hardness and heart rate variability as potential underlying mediators, and to explore a possible dose-response relationship between foam rolling volume and blood pressure through an inter-set analysis. Additionally, the acute effects of cervical foam rolling on local range of movement were also investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 7, 2026

Last Update Submit

February 21, 2026

Conditions

Keywords

blood pressureheart rate variabilitystiffnessmassage rollerrange of motionflexibilitycervical

Outcome Measures

Primary Outcomes (4)

  • Systolic pressure, diastolic pressure, and mean arterial pressure

    Systolic and diastolic BP were measured by using a validated oscillometric device. During the blood pressure assessment, participants were instructed to remain seated and relaxed. The mean arterial pressure (MAP) was subsequently extrapolated using the following formula: MAP=DP+1/3(SP-DP).

    - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.

  • Tissue Hardness

    Tissue hardness was collected using a portable tissue hardness meter. In the cervical region, the spinous process of C7 was used as the reference point. Measurements were obtained bilaterally to the C7.

    - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.

  • Heart rate variability

    Heart rate variabity was collected using a Polar H10 sensor chest strap device, a device validated for assessment of RR intervals.

    - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.

  • Cervical range of motion (ROM)

    Cervical ROM was measured using an inertial measurement unit (GYKO; Microgate, Bolzano, Italy). The accelerometer was secured to the participant's forehead and measured active cervical flexion, extension, right and left rotation, and right and left inclination.

    - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.

Study Arms (2)

Cervical foam rolling

EXPERIMENTAL

Four sets of 45 foam rolls were self-administered on the right posterolateral cervical region, with 45 seconds of recovery between sets.

Other: Cervical foam rolling

Control

NO INTERVENTION

Participants in the control condition remained seated for 6 minutes, matching the duration of the FR intervention protocol.

Interventions

FR condition: Four sets of 45 foam rolls were self-administered, by using a massage roller, on the right posterolateral cervical region, with 45 seconds of recovery between sets.

Cervical foam rolling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy participants aged 18 years or older

You may not qualify if:

  • use of antihypertensive medication;
  • orthopedic, neurological, renal, metabolic, or cardiovascular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ewan Thomas - Associate Professor, Department of Psychology, Educational Science, and Human Movement

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 25, 2026

Study Start

May 26, 2025

Primary Completion

July 30, 2025

Study Completion

July 31, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations