NCT04571034

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

September 25, 2020

Last Update Submit

December 8, 2022

Conditions

Keywords

massagerollerquadriceps

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • Change in Quadriceps Natural Oscillation Frequency

    1 hour (at baseline, immediately after treatment and 30 minutes later)

  • Change in Quadriceps Elasticity

    1 hour (at baseline, immediately after treatment and 30 minutes later)

  • Change in Quadriceps Relaxation Time

    1 hour (at baseline, immediately after treatment and 30 minutes later)

  • Change in Quadriceps Creep

    1 hour (at baseline, immediately after treatment and 30 minutes later)

Study Arms (3)

Control Group

SHAM COMPARATOR

Healthy adults receiving sham comparator.

Procedure: Sham Therapeutic Ultrasound

Medium-Intensity Roller Massage

EXPERIMENTAL

Healthy adults receiving medium-intensity roller massage.

Procedure: Medium-Intensity Roller Massage

High-Intensity Roller Massage

EXPERIMENTAL

Healthy adults receiving high-intensity roller massage.

Procedure: High-Intensity Roller Massage

Interventions

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

Control Group

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).

Medium-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).

High-Intensity Roller Massage

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Study Officials

  • Jeffrey Sykora, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

September 25, 2020

First Posted

September 30, 2020

Study Start

February 9, 2021

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations