NCT03662152

Brief Summary

Purpose: To compare the effects between non-vibration foam rolling (NVFR) and vibration foam rolling (VFR) on visual analogic scale (VAS), pressure pain threshold (PPT), oxygen saturation (SmO2), counter-movement jump (CMJ), and hip and knee range of movement (ROM) after induction of muscle damage through eccentric acute-exercise using inertial flywheel. Methods: Thirty-eight healthy subjects (males n=32 females= 6, age 22.2±3.2 years) were randomly assigned in a counter-balanced fashion to either a VFR or NVFR protocol group. All subjects performed a 10x10 (sets x reps) eccentric squat protocol to induce muscle damage. The protocols were administered 48-h post-exercise, measuring VAS, PPT, SmO2, CMJ and ROM, before and immediately post-treatment. The technique of treatment was repeated on both legs for 1 min for a total of 5 sets, with a 30-s rest between sets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

July 30, 2018

Last Update Submit

September 7, 2018

Conditions

Keywords

foam rollervibration foam rollerpressure pain thresholdoxygen saturationcountermovement jumpsoreness

Outcome Measures

Primary Outcomes (3)

  • visual-analogue scale (VAS)

    used to measure DOMS and to estimate the intensity of its associated pain. In order to standardize the scaling instructions, the endpoints were described for the subject as 0 = 'no sensation' and 10 = 'the most worst intense sensation imaginable' (16,40). The VAS was measured in four different conditions: 1) passive, 2) during isometric quadriceps contraction, 3) performing a squat and 4) during stretch quadriceps.

    2 seconds

  • Pressure pain threshold

    measured using a digital pressure algometer (Microfet3 ®, Hoggan Health Industries). The digital dynamometer with a 1 cm probe was used to measure three points at the quadriceps: vastus lateralis (VL), rectus femoris (RF) and vastus medialis (VM). Subject was lying on the stretcher, the algometer was positioned perpendicularly to the skin at each point and gradual pressure was applied until the subject reported a change from the sensation of pressure to pain. In that point the pressure was stopped immediately and the value was recorded represented the pain threshold (16). The mean of the 3 measures was calculated. Algometry has been shown to be highly reliable (ICC = 0.91) (9).

    1 minute

  • Muscle oxygenation

    was recorded at rest, during 10 squat repetitions (body weight load) and immediately after, using a commercially available portable non-invasive near infrared spectroscopy (NIRS) device (Moxy, Fortiori Design LLC, Minnesota, USA).

    2 minutes

Secondary Outcomes (2)

  • Infrared Optojump photoelectric cells (Microgate Corporation, Bolzano, Italy)

    5 minutes

  • Passive and active hip extension and knee flexion ROM of the dominant leg

    2 minutes

Study Arms (2)

Foam roller

EXPERIMENTAL

Non-Vibration Foam Rolling (NVFR) Group: subjects performed the FR protocol using a custom-made foam roller composed of a polystyrene foam cylinder (15-cm diameter × 35-cm long).

Device: Foam roller

vibration foam roller

EXPERIMENTAL

Vibration Foam Rolling (VFR) Group: subjects performed the same protocol using a foam roller with vibration (frequency: 18 Hz) composed of a polystyrene foam cylinder (15-cm diameter × 35-cm long) (Hyperice ®).

Device: Vibration foam roller

Interventions

Foam roller massage after DOMS

Foam roller

Foam roller massage with vibration after DOMS

vibration foam roller

Eligibility Criteria

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

You may qualify if:

  • All subjects were free from musculoskeletal disorders in the last year. All subjects were asked to abstain from unaccustomed exercise, all medications and dietary supplements 72 hours before baseline measurements, during the experimental period and post-treatment

You may not qualify if:

  • Subjects with symptoms or pathology,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Superior de Estudios Universitarios La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor of data was blinded to statistics investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 30, 2018

First Posted

September 7, 2018

Study Start

January 7, 2018

Primary Completion

May 11, 2018

Study Completion

June 30, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations