Effects of Roller Massage on Short-Term Passive Muscle Stiffness

December 8, 2022 updated by: Jeffrey Sykora
Muscle stiffness is associated with a variety of variables that affect health, however there is limited research on the effect of massage on muscle stiffness, and existing research does not quantify the intensity of massage. Thus trial will determine the effect of roller massage on quadriceps muscle stiffness and passive range of motion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Following screening for eligibility and consent, subjects will be assigned randomly to one of three groups: a placebo control group and two roller massage groups (treatment groups). The treatment groups will each receive a single bout of roller massage. One treatment group will receive a massage at medium intensity (25 newtons of force directed perpendicular to surface of thigh), the other treatment group at high intensity (45 newtons of force directed perpendicular to surface of thigh). The placebo group will receive a single bout of sham ultrasound. Both placebo and treatments will be delivered to the anterior thigh with the participant in a supine position. Each procedure will last for 10 minutes. In all groups, muscle stiffness, natural oscillation frequency, elasticity, relaxation time, and creep at the vastus lateralis will be measured using a myotonometer. PROM for knee flexion will also be measured in both groups using goniometry. All measurements will be taken at 3 different times: immediately before treatment or placebo, immediately after treatment or placebo, and 30 minutes after treatment or placebo. Myotonometric measurements of the vastus lateralis will be taken 2/3 of the way down between the anterior superior iliac spine and lateral aspect of the patella, in accordance with guidelines for the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles. For goniometric measurement, participants will be in supine position on an examination table. The investigator will flex the participant's hip to 90 degrees and then, using a dynamometer (to ensure consistent applied force for all participants), flex the participant's knee. To measure knee flexion PROM, the goniometer will be positioned with the axis at the lateral epicondyle of the femur, the stationary arm in line with the lateral midline of the femur toward the greater trochanter, and the moving arm in line with the fibular head and lateral malleolus. During the time between the second and third measurements, subjects will be asked to sit quietly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Age 18-30

Exclusion Criteria:

  • Prior history of significant vascular or neuromuscular illness or impairment affecting the lower limbs
  • Serious injuries to the back or legs in the last six months
  • Discomfort or pain in the back or legs
  • Use of pain and anti-inflammatory medications
  • Any contraindications to massage treatment or ultrasound
  • Body mass index (BMI) >30 kg/m2.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control Group
Healthy adults receiving sham comparator.
Procedure: Sham Therapeutic Ultrasound
A standard ultrasound machine (Vectratm by Chattanooga Group, Inc.) with inactive probe will be used to deliver sham massage.
Experimental: Medium-Intensity Roller Massage
Healthy adults receiving medium-intensity roller massage.
Procedure: Medium-Intensity Roller Massage
This group will receive a single bout of roller massage at medium intensity (25 newtons of force directed perpendicular to the surface of the thigh).
Experimental: High-Intensity Roller Massage
Healthy adults receiving high-intensity roller massage.
Procedure: High-Intensity Roller Massage
This group will receive a single bout of roller massage at medium intensity (45 newtons of force directed perpendicular to the surface of the thigh).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Quadriceps Stiffness
Time Frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Quadriceps stiffness will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Passive Range of Motion
Time Frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Range of motion of the knee will be measured using a goniometer at baseline, immediately after treatment, and 30 minutes later.
1 hour (at baseline, immediately after treatment and 30 minutes later)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quadriceps Natural Oscillation Frequency
Time Frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Quadriceps natural oscillation frequency will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Quadriceps Elasticity
Time Frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Quadriceps elasticity will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Quadriceps Relaxation Time
Time Frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Quadriceps relaxation time will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Quadriceps Creep
Time Frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Quadriceps creep will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
1 hour (at baseline, immediately after treatment and 30 minutes later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jeffrey Sykora

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Sykora, PhD, University of Kentucky

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings