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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04571034
Other study ID # 60480
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2021
Est. completion date July 13, 2021

Study information

Verified date December 2022
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Thus trial will determine the effect of roller massage on quadriceps muscle stiffness and passive range of motion.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 13, 2021
Est. primary completion date July 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sham Therapeutic Ultrasound
A standard ultrasound machine (Vectratm by Chattanooga Group, Inc.) with inactive probe will be used to deliver sham massage.
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).
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).

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Jeffrey Sykora

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Quadriceps Stiffness 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)
Primary 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. 1 hour (at baseline, immediately after treatment and 30 minutes later)
Secondary 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. 1 hour (at baseline, immediately after treatment and 30 minutes later)
Secondary Change in Quadriceps Elasticity 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)
Secondary Change in Quadriceps Relaxation Time 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)
Secondary Change in Quadriceps Creep 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)
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