Healthy ParticipantsNCT07433543
Foam Rolling, Blood Pressure and Range of Motion
A study testing Cervical foam rolling in people with Healthy Participants and Healthy Young Adults, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Healthy Young Adults
- What is being tested?
- Cervical foam rolling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 26 May 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy participants aged 18 years or older
Who cannot join
- use of antihypertensive medication;
- orthopedic, neurological, renal, metabolic, or cardiovascular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Blood Pressure and Range of Motion Responses to Cervical Foam Rolling: a Randomized Controlled Crossover Trial
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.
- Conditions
- Healthy Participants, Healthy Young Adults
- Being tested
- Cervical foam rolling
- Keywords
- blood pressure, heart rate variability, stiffness, massage roller, range of motion, flexibility, cervical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical foam rollingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: - 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.
Measured: - 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.
Measured: - 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.
Measured: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start26 May 2025
- Primary completion30 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewan Thomas, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433543
- Sponsor's protocol ID
- 60625-2025
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Blood Pressure and Range of Motion Responses to Cervical Foam Rolling: a Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT07433543
- Acronym / sponsor ID
- 60625-2025
- Conditions
- Healthy Participants, Healthy Young Adults
- Keywords
- blood pressure, heart rate variability, stiffness, massage roller, range of motion, flexibility, cervical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical foam rolling | Experimental | Other: Cervical foam rollingFour sets of 45 foam rolls were self-administered on the right posterolateral cervical region, with 45 seconds of recovery between sets. |
| Control | No intervention | –Participants in the control condition remained seated for 6 minutes, matching the duration of the FR intervention protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy participants aged 18 years or older
Key exclusion criteria (2 listed)
- use of antihypertensive medication;
- orthopedic, neurological, renal, metabolic, or cardiovascular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical foam rollingFR 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. | Other | Cervical foam rolling |
Primary outcome
Systolic pressure, diastolic pressure, and mean arterial pressure
Time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
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).
Tissue Hardness
Time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
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.
Heart rate variability
Time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
Heart rate variabity was collected using a Polar H10 sensor chest strap device, a device validated for assessment of RR intervals.
Cervical range of motion (ROM)
Time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical foam rolling in people with Healthy Participants and Healthy Young Adults, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic pressure, diastolic pressure, and mean arterial pressure (time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.