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Athletic InjuriesFRvsMTAthNCT04161300

Foam Rolling and Orthopaedic Manual Physical Therapy in Athletes

A study testing Foam Rolling (FR) and Orthopaedic Manual Physical Therapy Group (OMPT) in people with Athletic Injuries, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of the present study was to evaluate whether FR massage is effective in improving dynamic balance, flexibility and dynamic strength after intense exercise recovery compared to OMPT protocol or a control group. The present study was a randomized controlled trial. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Athletic Injuries
What is being tested?
Foam Rolling (FR) and Orthopaedic Manual Physical Therapy Group (OMPT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSpain
Study dates
15 Nov 2019to 18 Feb 2020
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

  • male and female amateur athletes

Who cannot join

  • previous surgery of the locomotor system in lower limbs
  • musculoskeletal injuries in any part of the body that prevent practicing sports understanding or communication difficulties
  • insufficient fluency in the Spanish language to follow measurement instructions.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Gemma v. Espí López

    Valencia, 46010

Other trials in Spain

About this study

Official title: Comparison Between Foam Rolling and Orthopaedic Manual Physical Therapy on Functional Variables in Athletes: A Randomized Controlled Trial

The main objective of the present study was to evaluate whether FR massage is effective in improving dynamic balance, flexibility and dynamic strength after intense exercise recovery compared to OMPT protocol or a control group. The present study was a randomized controlled trial. Amateur athletes will be recruited from two athletic clubs. Participants will be randomizing and allocating into three non-balanced groups through a computer software by an external assistant who will be blinding to the study objectives: FR group (n = 18), OMPT group (n = 15) and control group (CG) (n = 14). The intervention period will be lasting one day (1 session). Participant assessment will be perform twice: prior to the study (pre-intervention) and immediately after finishing the intervention (post-intervention).

Interventions: FR group. FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes; OMPT group. Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; The total duration will be approximately 10-15 minutes.; CG. The CG did not receive any intervention.

Outcomes will be Lumbar flexibility, Hip flexion, Dynamic balance, Standing Jump and Impression of Change.

Read the detailed description

Introduction Foam rolling (FR) is a form of self-massage in which the targeted musculature is rolled and compressed using a FR. In the field of physical therapy that has been shown to produce a reduced feeling of fatigue in healthy athletes12 as well as hypoalgesic effects in subjects with delayed-onset muscle soreness.

Currently, self-massage through FR is commonly used in the sports field. The reason for this is that it has been suggested that it could have the positive effects traditionally associated with orthopedic manual physical therapy (OMPT), That is why despite the widespread use of FR massage in the field of muscle recovery in athletes, there is a lack of scientific literature about its effectiveness compared to OMPT that can justify its use. Therefore, the main objective of the present study was to evaluate whether FR massage is effective in improving dynamic balance, flexibility and dynamic strength after intense exercise recovery compared to OMPT protocol or a control group.

Methods The present study was a randomized controlled trial. Participants Amateur athletes will be recruited from two athletic clubs. The inclusion criteria will be as follows: (a) male and female amateur athletes aged 18 to 30 years. The exclusion criteria: (a) previous surgery of the locomotor system in lower limbs; (b) musculoskeletal injuries in any part of the body that prevent practicing sports; (c) understanding or communication difficulties; and (d) insufficient fluency in the Spanish language to follow measurement instructions.

Informed written consent will be obtaining from all the participants prior to inclusion. All the participants will be explaining the study procedures, which will be design according to the ethical standards of the Helsinki Declaration.

Procedure Participants will be randomizing and allocating into three non-balanced groups through a computer software by an external assistant who will be blinding to the study objectives: FR group (n = 18), OMPT group (n = 15) and control group (CG) (n = 14). The intervention period will be lasting one day (1 session).

Participant assessment will be perform twice: prior to the study (pre-intervention) and immediately after finishing the intervention (post-intervention).

Interventions FR group. FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes.

OMPT group. Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; b) Hip joint decompression, performing 25 repetitions c) Hip rotator stretch with hip and knee flexion, 15 repetitions; d) Femorotibial decompression, 25 reps. e) Quadriceps femoral muscle compression and traction, 25 repetitions; f) Opening of the internal and external femorotibial interline, 15 repetition; g) Ankle decompression, 3 repetitions; h) Posteroanterior and anteroposterior mobilization of head and base of fibula, 25 repetitions. The total duration will be approximately 10-15 minutes.

CG. The CG did not receive any intervention.

Primary outcomes: Physical functional variables Lumbar flexibility. Modified Schober test (MMST). The MMST was designed to assess the mobility of the entire lower back, so the MMST was used to measure lumbar flexion before and after FR and TM interventions. The examiner will place his thumbs on the lower margin of the posterior-upper iliac spine (lower reference point) and a pen mark was made. While the examiner held the tape against the subject's skin, another signal was marked 15 cm above the first (upper reference point). Each subject was then asked to perform an active flexion of the entire trunk and the distance between the two points will be measuring and then the subject return to his initial position. The difference between the initial distance and the new bending measurements will be take.

Hip flexion. by the passive straight leg raise (SLR). Passive SLR will be conducting using a procedure previously described by Hopper et al. A Richards splint and an ankle foot orthosis were applied to the left leg to maintain the knee in full extension and the ankle at a neutral plantar angle. An inclinometer will be attaching to a belt, which will place around the pelvis at the level of the anterior superior iliac spine (Baseline Bubble Inclinometer. Fabrication Enterprises, PO Box, 1500 White Plains, NY 10602, USA). A second inclinometer will be then attaching to the Richards splint at the level of the knee joint line. The mean of 3 measures will be using for analysis. During the test, the participants are positioned with their hands on the abdomen, cervical spine in a neutral position and eyes closed.

Dynamic balance using the Star Excursion Balance Test (SEBT). The SEBT is a dynamic test that requires strength, flexibility, and proprioception. The goal of the SEBT is to maintain single-leg stance while reaching as far as possible with the contralateral leg. Subjects are instructed to stand with both feet positioned inside the boundaries of the starting box. The test initiates when the subject begins to reach in one of the four diagonal directions.

Standing Jump. Subjects are placed their feet shoulder-width apart and toes placed in a line on the floor. The subjects then made a horizontal leap forward, where they were allowed the arms to swing, and it will be done along the length of a tape measure that was fixed to the ground. The subjects had to stick to the ground in the landing phase, preventing any additional movement of the feet when landing.

The jumped distance will be calculating as the distance from the jump initiation line to the heel of the back foot. The best of three attempts was recorded, with a recovery of 60 seconds between attempts. All distances will be measuring with an accuracy of 0.01 meters.

Secondary outcome:

Impression of Change (CGI). Patient Global Impression of Change Scale (PGIOCS) that evaluates the change perceived by the subject after a treatment. This scale has 7 affirmations to choose from (I have improved a lot, quite, a little, I am the same, I have worsened a little, a lot or a lot) and a pain analogue scale of 10 cm.

Being tested
Foam Rolling (FR), Control Group (CG), Orthopaedic Manual Physical Therapy Group (OMPT)
Medical subject headings
Athletic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foam Rolling (FR)Other

    FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes.

  • Control Group (CG)Other

    The CG did not receive any intervention.

  • Orthopaedic Manual Physical Therapy Group (OMPT)Other

    Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; b) Hip joint decompression, performing 25 repetitions c) Hip rotator stretch with hip and knee flexion, 15 repetitions; d) Femorotibial decompression, 25 reps. e) Quadriceps femoral muscle compression and traction, 25 repetitions; f) Opening of the internal and external femorotibial interline, 15 repetition; g) Ankle decompression, 3 repetitions; h) Posteroanterior and anteroposterior mobilization of head and base of fibula, 25 repetitions. The total duration will be approximately 10-15 minutes.

Study groups in NCT04161300
Study groupRoleWhat they receive
Foam Rolling Group (FR)Active comparatorNot described
Receives: Other: Foam Rolling (FR)
Orthopaedic Manual Physical Therapy Group (OMPT)Active comparatorNot described
Receives: Other: Orthopaedic Manual Physical Therapy Group (OMPT)
Control Group (CG)OtherNot described
Receives: Other: Control Group (CG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dynamic balance

    Dynamic balance using the Star Excursion Balance Test (SEBT). The SEBT is a dynamic test that requires strength, flexibility, and proprioception. The goal of the SEBT is to maintain single-leg stance while reaching as far as possible with the contralateral leg. Subjects are instructed to stand with both feet positioned inside the boundaries of the starting box. The test initiates when the subject begins to reach in one of the four diagonal directions.

    Measured: 1 day

Secondary outcomes (4)
  1. Perception of Change

    Patient Global Impression of Change Scale (PGIOCS) that evaluates the change perceived by the subject after a treatment. This scale has 7 levels which represent improvement from 1 to 3, 4 indicates no change and 5 to 7 indicates worsening. In addition, it includes a visual analog scale which scores range from 0 to 10 where 0 is much better and 10 much worse.

    Measured: 1 day

  2. Lumbar flexibility

    Modified Schober test (MMST). The MMST was designed to assess the mobility of the entire lower back, so the MMST was used to measure lumbar flexion before and after FR and TM interventions. The examiner will place his thumbs on the lower margin of the posterior-upper iliac spine (lower reference point) and a pen mark was made. While the examiner held the tape against the subject's skin, another signal was marked 15 cm above the first (upper reference point). Each subject was then asked to perform an active flexion of the entire trunk and the distance between the two points will be measuring and then the subject return to his initial position. The difference between the initial distance and the new bending measurements will be take.

    Measured: 1 day

  3. Hip flexion

    Hip flexion by the passive straight leg raise (SLR). Passive SLR will be conducting using a procedure previously described by Hopper et al. A Richards splint and an ankle foot orthosis were applied to the left leg to maintain the knee in full extension and the ankle at a neutral plantar angle. An inclinometer will be attaching to a belt, which will place around the pelvis at the level of the anterior superior iliac spine (Baseline Bubble Inclinometer. Fabrication Enterprises, PO Box, 1500 White Plains, NY 10602, USA). A second inclinometer will be then attaching to the Richards splint at the level of the knee joint line. The mean of 3 measures will be using for analysis. During the test, the participants are positioned with their hands on the abdomen, cervical spine in a neutral position and eyes closed.

    Measured: 1 day

  4. Standing Jump

    Subjects are placed their feet shoulder-width apart and toes placed in a line on the floor. The subjects then made a horizontal leap forward, where they were allowed the arms to swing, and it will be done along the length of a tape measure that was fixed to the ground. The subjects had to stick to the ground in the landing phase, preventing any additional movement of the feet when landing.

    The jumped distance will be calculating as the distance from the jump initiation line to the heel of the back foot. The best of three attempts was recorded, with a recovery of 60 seconds between attempts. All distances will be measuring with an accuracy of 0.01 meters.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start15 Nov 2019
  3. Primary completion15 Jan 2020
  4. Study completion18 Feb 2020

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04161300
Sponsor's protocol ID
ID0027
Acronym
FRvsMTAth
Status last verified
Feb 2021
First submitted
8 Nov 2019
Last updated
2 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Espi-Lopez GV, Ruescas-Nicolau MA, Castellet-Garcia M, Suso-Marti L, Cuenca-Martinez F, Marques-Sule E. Effectiveness of Foam Rolling vs. Manual Therapy in Postexercise Recovery Interventions for Athletes: A Randomized Controlled Trial. J Strength Cond Res. 2023 Jun 1;37(6):e361-e368. doi: 10.1519/JSC.0000000000004383. Epub 2022 Dec 19.

    PubMed 36534492

Questions about this trial

What is this clinical trial studying?

A study testing Foam Rolling (FR) and Orthopaedic Manual Physical Therapy Group (OMPT) in people with Athletic Injuries, run by University of Valencia 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 3 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 2 Mar 2021. 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?

Dynamic balance (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04161300, which also lists 1 linked publication.

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 2 Mar 2021.

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