- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520474
Roller Massage and Blood Pressure
April 2, 2026 updated by: Ewan Thomas, University of Palermo
Association Between Reductions in Tissue Hardness and Acute Decreases in Blood Pressure Following Roller Massage: A Randomized Controlled Crossover Trial
Roller massage (RM), frequently described within the broader framework of self-myofascial release, has emerged as a widely adopted modality among rehabilitation practitioners and physically active populations.
Previous investigations on RM have reported improvements in joint range of motion, small to trivial enhancements in selected performance measures, attenuation of exercise-induced muscle soreness, and reductions in pain perception.
While the evidence base supporting mobility, performance, muscle soreness and pain sensitivity adaptations is relatively well developed, considerably less attention has been directed toward the blood pressure responses to RM and the potential underlying mechanisms.
Consequently, the physiological impact of RM on cardiovascular regulation remains insufficiently characterized and requires further systematic investigation.
An acute reduction in blood pressure may be postulated, potentially mediated by mechanisms involving changes in total peripheral resistance, which could be linked to modifications in tissue mechanical characteristics.
In parallel, a contributory role of autonomic regulation cannot be excluded, as shifts in sympathetic and parasympathetic activity may also influence cardiovascular responses.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sicily
-
Palermo, Sicily, Italy, 90144
- University of Palermo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy participants aged 18 years or older.
Exclusion Criteria:
- orthopedic disorders
- neurological disorders
- renal disorders
- metabolic disorders
- musculoskeletal disorders
- cardiovascular disorders
- use of antihypertensive medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Roller Massage Intervention (RM)
The RM intervention was conducted using a Theraband® Roller Massager (The Hygenic Corporation, Akron, OH, USA).
All procedures were performed exclusively on the right thigh and administered by the same investigator to ensure methodological consistency.
The protocol included a total of eight sets, four per muscle group, resulting in an overall intervention duration of 4 minutes (2 minutes allocated to the hamstrings and 2 minutes to the quadriceps).
Each muscle group underwent four sets of 30 rolling repetitions executed at a controlled cadence of one repetition per second, yielding 30 seconds of continuous rolling per set.
|
The RM intervention was conducted using a Theraband® Roller Massager (The Hygenic Corporation, Akron, OH, USA).
All procedures were performed exclusively on the right thigh and administered by the same investigator to ensure methodological consistency.
The protocol included a total of eight sets, four per muscle group, resulting in an overall intervention duration of 4 minutes (2 minutes allocated to the hamstrings and 2 minutes to the quadriceps).
Each muscle group underwent four sets of 30 rolling repetitions executed at a controlled cadence of one repetition per second, yielding 30 seconds of continuous rolling per set.
|
|
No Intervention: Passive Control Session
During the passive control condition, participants remained in a supine position on a standard medical examination bed for 8 minutes.
This duration was matched to the total time required for the RM protocol, thereby ensuring temporal equivalence between conditions.
Throughout the period between the T0 and T1 assessments, no active interventions were administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Systolic and diastolic blood pressure were assessed in the supine position using a validated automated oscillometric monitor (Omron MX3 Plus; Omron Healthcare, model HEM-742-E).
Mean arterial pressure (MAP) and rate pressure product (RPP) were subsequently derived using conventional formulas.
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 variability (HRV) was recorded with participants resting supine on a medical examination table for an additional 5 minutes under quiet and controlled conditions.
During this recording phase, beat-to-beat RR intervals were continuously monitored using a validated Polar H10 chest-strap heart rate sensor (Polar Electro Oy, Kempele, Finland).
HRV metrics were derived from both time-domain and frequency-domain analyses, providing a comprehensive evaluation of cardiac autonomic modulation.
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
|
Tissue Hardness
Time Frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Tissue hardness (TH) was quantified in Newton using a portable tissue hardness meter (NEUTONE TDM-N1; TRY-ALL Corp., Chiba, Japan).
For hamstring evaluation, the ischial tuberosity and the popliteal fossa were used as proximal and distal anatomical reference points, respectively.
Two measurement sites were identified within the proximal third of the posterior right thigh: a lateral site corresponding to the biceps femoris and a medial site corresponding to the semitendinosus/semimembranosus complex.
Quadriceps TH was assessed using the anterior superior iliac spine (ASIS) as the proximal landmark, and the superior border of the patella as the distal landmark.
(1) the midpoint between the ASIS and the superior patellar border, and (2) a point located at the proximal third of the same linear distance.
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2025
Primary Completion (Actual)
July 31, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
April 2, 2026
First Submitted That Met QC Criteria
April 2, 2026
First Posted (Actual)
April 9, 2026
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RM-BP 60625-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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