Muscle TightnessNCT04571034
Effects of Roller Massage on Short-Term Passive Muscle Stiffness
A study testing Medium-Intensity Roller Massage and High-Intensity Roller Massage in people with Muscle Tightness, run by Jeffrey Sykora at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness
- What is being tested?
- Medium-Intensity Roller Massage and High-Intensity Roller Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 13 Jul 2021
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Age 18-30
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Tightness
- Being tested
- Sham Therapeutic Ultrasound, Medium-Intensity Roller Massage, High-Intensity Roller Massage
- Keywords
- massage, roller, quadriceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Therapeutic UltrasoundProcedure or surgery
A standard ultrasound machine (Vectratm by Chattanooga Group, Inc.) with inactive probe will be used to deliver sham massage.
Medium-Intensity Roller MassageProcedure or surgery
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).
High-Intensity Roller MassageProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Healthy adults receiving sham comparator. Receives: Procedure: Sham Therapeutic Ultrasound |
| Medium-Intensity Roller Massage | Experimental | Healthy adults receiving medium-intensity roller massage. Receives: Procedure: Medium-Intensity Roller Massage |
| High-Intensity Roller Massage | Experimental | Healthy adults receiving high-intensity roller massage. Receives: Procedure: High-Intensity Roller Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps Stiffness
Quadriceps stiffness will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
Measured: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Passive Range of Motion
Range of motion of the knee will be measured using a goniometer at baseline, immediately after treatment, and 30 minutes later.
Measured: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Secondary outcomes (4)
Change in Quadriceps Natural Oscillation Frequency
Quadriceps natural oscillation frequency will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
Measured: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Quadriceps Elasticity
Quadriceps elasticity will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
Measured: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Quadriceps Relaxation Time
Quadriceps relaxation time will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
Measured: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Change in Quadriceps Creep
Quadriceps creep will be measured using a myotonometer at baseline, immediately after treatment, and 30 minutes later.
Measured: 1 hour (at baseline, immediately after treatment and 30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start9 Feb 2021
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TightnessStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Sykora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey Sykora, University of Kentucky
- Investigators
- Jeffrey Sykora, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571034
- Sponsor's protocol ID
- 60480
- Status last verified
- Dec 2022
- First submitted
- 25 Sep 2020
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Roller Massage on Short-Term Passive Muscle Stiffness
- ClinicalTrials.gov ID
- NCT04571034
- Acronym / sponsor ID
- 60480
- Conditions
- Muscle Tightness
- Keywords
- massage, roller, quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jeffrey SykoraUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 30 Sep 2020 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Procedure: Sham Therapeutic UltrasoundHealthy adults receiving sham comparator. |
| Medium-Intensity Roller Massage | Experimental | Procedure: Medium-Intensity Roller MassageHealthy adults receiving medium-intensity roller massage. |
| High-Intensity Roller Massage | Experimental | Procedure: High-Intensity Roller MassageHealthy adults receiving high-intensity roller massage. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Age 18-30
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Sham Therapeutic UltrasoundA standard ultrasound machine (Vectratm by Chattanooga Group, Inc.) with inactive probe will be used to deliver sham massage. | Procedure or surgery | Control Group |
| Medium-Intensity Roller MassageThis group will receive a single bout of roller massage at medium intensity (25 newtons of force directed perpendicular to the surface of the thigh). | Procedure or surgery | Medium-Intensity Roller Massage |
| High-Intensity Roller MassageThis group will receive a single bout of roller massage at medium intensity (45 newtons of force directed perpendicular to the surface of the thigh). | Procedure or surgery | High-Intensity Roller Massage |
Primary outcome
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.
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.
4 secondary outcomes
Change in Quadriceps Natural Oscillation Frequency
Time frame: 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)
Change in Quadriceps Relaxation Time
Time frame: 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)
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 9 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Jeffrey Sykora, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium-Intensity Roller Massage and High-Intensity Roller Massage in people with Muscle Tightness, run by Jeffrey Sykora at 1 site in United States.
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 6 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 9 Dec 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in Quadriceps Stiffness (time frame: 1 hour (at baseline, immediately after treatment and 30 minutes later)). The study lists 2 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 9 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.