NCT02919527

Brief Summary

Treatment or training of fascial tissues has moved into the focus of medical research in the last decade. In this context, the use of foam rollers or roller massagers for self-myofascial-release (SMR) techniques has become increasingly popular in health and fitness professionals. The primary objective of these techniques is to mimic manual massage or myofascial-release therapy with a self-usable tool. Recent studies suggest that SMR improves, inter alia, range of motion (ROM) without a decrease in neuromuscular performance (Cheatham et al. 2015). Concurrent effects on the muscle and especially the surrounding connective tissue network have been proposed as underlying mechanisms for these observed changes in ROM after SMR. Several authors assume a positive effect of SMR on sliding properties of different independent fascial layers. Also, changes in passive tissue stiffness is suggested. Passive stiffness is thereby characterized by passive resistance in the tissues' (muscles') functional direction, the passive resistive torque (PRT). In conclusion, for many of the proclaimed effects of SMR, such as improvements of sliding of fascial layers or decreases of passive stiffness, there is a lack of evidence in the literature. Therefore, the aim of the study is to evaluate acute effects of SMR on the viscoelastic properties of the muscles on the anterior thigh and the corresponding fascia. In a cross over design, 16 subjects receive all of the following interventions after a familiarization session: a) 2x60 seconds of SMR at the anterior thigh, b) 2x60 seconds of static stretching at the anterior thigh, c) no intervention in a balanced permutated randomization sequence. Before and directly after each intervention, outcome parameters are collected. Passive Resistive Torque is evaluated using a computerized isokinetic dynamometer. In passive mode, the lower leg is moved from full knee extension (0°) to the point of maximal knee flexion with a velocity of 5°/s. Torque and angle are recorded at 100 Hertz (Hz). Sliding of fascial layers is quantified with a frame-by-frame cross correlation algorithm of high-resolution ultrasound images (Dilley et al. 2001). First stretch sensation is quantified using the passive mode in the isokinetic dynamometer. Maximal ROM is detected using a an ultrasonographic movement analysis system in a prone position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

September 27, 2016

Last Update Submit

November 28, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Passive-Resistive-Torque, Biodex System 3 Professional

    In passive mode, the lower leg is moved from full knee extension (0°) to the point of maximal knee flexion with a velocity of 5°/s. Torque and angle are recorded at 100 Hz, and passive stiffness can be calculated from the torque-angle relationship.

    1 minute

  • Fascial-Sliding, Siemens Acuson X300, Cross correlation

    Sliding of fascial layers is quantified with a frame-by-frame cross correlation algorithm of high-resolution ultrasound images. The cross-correlation method calculates the correlation coefficient between the pixel grey levels for selected rectangle-shaped regions of interest (ROIs) in two adjacent images. The pixel shift that gives the maximum correlation coefficient corresponds to the relative movement between two frames.

    1 minute

Secondary Outcomes (2)

  • Maximal Range of Motion, Zebris CMS20

    1 minute

  • First stretch sensation, Biodex System 3 Professional

    1 minute

Study Arms (3)

Self-Myofascial-Release

EXPERIMENTAL

Two 60 seconds bouts of Self-Myofascial-Release performed at the anterior thigh; anticipated intensity of 7/10 on a 10 point numeric rating scale (0 representing no discomfort and 10 representing maximal discomfort)

Other: Self-Myofascial-Release

Stretching

ACTIVE COMPARATOR

Two 60 seconds bouts of static stretching performed at the anterior thigh; anticipated intensity of 7/10 on a 10 point numeric rating scale (0 representing no discomfort and 10 representing maximal discomfort)

Other: Stretching

Control

NO INTERVENTION

No Intervention

Interventions

Self-Myofascial-Release performed at the anterior thigh

Self-Myofascial-Release

Static Stretching performed at the anterior thigh

Stretching

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-40 years

You may not qualify if:

  • History of orthopedic injuries in the lower extremity in the last 12 months
  • Any history of psychiatric, cardiovascular, endocrine, neurological, or metabolic disorders
  • Any current medication that might affect pain perception or proprioception
  • Muscle soreness
  • Pregnancy/nursing period
  • Nonspecific musculoskeletal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Medicine, Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, 60487, Germany

Location

Related Publications (3)

  • Cheatham SW, Kolber MJ, Cain M, Lee M. THE EFFECTS OF SELF-MYOFASCIAL RELEASE USING A FOAM ROLL OR ROLLER MASSAGER ON JOINT RANGE OF MOTION, MUSCLE RECOVERY, AND PERFORMANCE: A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2015 Nov;10(6):827-38.

    PMID: 26618062BACKGROUND
  • Dilley A, Greening J, Lynn B, Leary R, Morris V. The use of cross-correlation analysis between high-frequency ultrasound images to measure longitudinal median nerve movement. Ultrasound Med Biol. 2001 Sep;27(9):1211-8. doi: 10.1016/s0301-5629(01)00413-6.

    PMID: 11597362BACKGROUND
  • Krause F, Wilke J, Niederer D, Vogt L, Banzer W. Acute effects of foam rolling on passive tissue stiffness and fascial sliding: study protocol for a randomized controlled trial. Trials. 2017 Mar 9;18(1):114. doi: 10.1186/s13063-017-1866-y.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations