- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571034
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
48
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
-
-
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
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 |
Intervention / Treatment |
---|---|
Sham Comparator: Control Group
Healthy adults receiving sham comparator.
|
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.
|
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.
|
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
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
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
Investigators
- 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)
February 9, 2021
Primary Completion (Actual)
July 13, 2021
Study Completion (Actual)
July 13, 2021
Study Registration Dates
First Submitted
September 25, 2020
First Submitted That Met QC Criteria
September 25, 2020
First Posted (Actual)
September 30, 2020
Study Record Updates
Last Update Posted (Estimate)
December 9, 2022
Last Update Submitted That Met QC Criteria
December 8, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID 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.
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