Pain, AcuteNCT03662152
Effects of Vibration Foam Rolling After Muscle Damage
A study testing Foam roller and Vibration foam roller in people with Pain, Acute, run by Daniel Muñoz-Garcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Foam roller and Vibration foam roller
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2018to 30 Jun 2018
- 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
- 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
Who cannot join
- Subjects with symptoms or pathology,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vibration Foam Rolling and Non-vibration Foam Rolling in Recovery After Exercise Induce Muscle Damage
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.
Read the detailed description
Muscle damage was induced with overload eccentric training using inertial flywheel (2.7-kg flywheels with a moment inertia of 0.07 kg m-2). Immediately after baseline measures, subjects performed 10 sets x 10 repetitions parallel squats using a gravity-free training device flywheel with 2 minutes of recovery between sets. The squat exercise was chosen as basic movement because of its similar muscles recruitment to many athletic movements patterns. Furthermore, the squat exercise is one of the main exercises used to improve the lower-body strength. The required technique was demonstrated to all subjects before beginning the eccentric session, and they were coached during the protocol to be sure adequate technique and maximal effort in each repetition were maintained. All participants performed 5 min on a treadmill to warm up before performing the eccentric bout.
Description of the foam roller intervention The foam-rolling technique was based on a previously published protocol. In both protocols, the technique was repeated on both legs for 1 min for a total of 5 sets, with a 30-s rest between sets. The cadence for both techniques (NVFR and VFR) was fixed at 3:4 using a metronome.
Using a protocol adapted from previous study, subjects began in the plank position with the foam roller at the most proximal portion of the quadriceps of both legs, with as much of their body mass as possible on the foam roller.
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).
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).
- Conditions
- Pain, Acute
- Being tested
- Foam roller, Vibration foam roller
- Keywords
- foam roller, vibration foam roller, pressure pain threshold, oxygen saturation, countermovement jump, soreness
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam rollerDevice
Foam roller massage after DOMS
Vibration foam rollerDevice
Foam roller massage with vibration after DOMS
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 ®). Receives: Device: Vibration foam roller |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 2 minutes
Secondary outcomes (2)
Infrared Optojump photoelectric cells (Microgate Corporation, Bolzano, Italy)
were used to measure explosive strength in lower limbs
Measured: 5 minutes
Passive and active hip extension and knee flexion ROM of the dominant leg
were measured with a Microfet3 ® inclinometer using the protocol of Norkin \& White
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start7 Jan 2018
- Primary completion11 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Muñoz-Garcia
- Sponsor type
- University, hospital or other
- Collaborators
- Camilo Jose Cela University
- Responsible party
- Sponsor-investigator, Daniel Muñoz-Garcia, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662152
- Sponsor's protocol ID
- CEI UCJC
- Status last verified
- Sep 2018
- First submitted
- 30 Jul 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Foam Rolling and Non-vibration Foam Rolling in Recovery After Exercise Induce Muscle Damage
- ClinicalTrials.gov ID
- NCT03662152
- Acronym / sponsor ID
- CEI UCJC
- Conditions
- Pain, Acute
- Keywords
- foam roller, vibration foam roller, pressure pain threshold, oxygen saturation, countermovement jump, soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Daniel Muñoz-GarciaUniversity, hospital or other
- Collaborators
- Camilo Jose Cela University
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Sep 2018 (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.
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.
Detailed description
Muscle damage was induced with overload eccentric training using inertial flywheel (2.7-kg flywheels with a moment inertia of 0.07 kg m-2). Immediately after baseline measures, subjects performed 10 sets x 10 repetitions parallel squats using a gravity-free training device flywheel with 2 minutes of recovery between sets. The squat exercise was chosen as basic movement because of its similar muscles recruitment to many athletic movements patterns. Furthermore, the squat exercise is one of the main exercises used to improve the lower-body strength. The required technique was demonstrated to all subjects before beginning the eccentric session, and they were coached during the protocol to be sure adequate technique and maximal effort in each repetition were maintained. All participants performed 5 min on a treadmill to warm up before performing the eccentric bout.
Description of the foam roller intervention The foam-rolling technique was based on a previously published protocol. In both protocols, the technique was repeated on both legs for 1 min for a total of 5 sets, with a 30-s rest between sets. The cadence for both techniques (NVFR and VFR) was fixed at 3:4 using a metronome.
Using a protocol adapted from previous study, subjects began in the plank position with the foam roller at the most proximal portion of the quadriceps of both legs, with as much of their body mass as possible on the foam roller.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foam roller | Experimental | Device: Foam rollerNon-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). |
| vibration foam roller | Experimental | Device: Vibration foam rollerVibration 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 ®). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects with symptoms or pathology,
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 |
|---|---|---|
| Foam rollerFoam roller massage after DOMS | Device | Foam roller |
| Vibration foam rollerFoam roller massage with vibration after DOMS | Device | vibration foam roller |
Primary outcome
visual-analogue scale (VAS)
Time frame: 2 seconds
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.
Pressure pain threshold
Time frame: 1 minute
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).
Muscle oxygenation
Time frame: 2 minutes
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 secondary outcomes
Infrared Optojump photoelectric cells (Microgate Corporation, Bolzano, Italy)
Time frame: 5 minutes
Passive and active hip extension and knee flexion ROM of the dominant leg
Time frame: 2 minutes
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 10 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam roller and Vibration foam roller in people with Pain, Acute, run by Daniel Muñoz-Garcia at 1 site in Spain.
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 1 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 10 Sep 2018. 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 Spain. 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. 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?
visual-analogue scale (VAS) (time frame: 2 seconds). The study lists 3 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 10 Sep 2018.