RuntNCT05392153

The Effect of Myofascial Release Technique on Sportive Performance, Balance and Injury Risk in Runners

A study testing Myofascial therapy in people with Runt, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

In order to investigate the effect of myofascial release technique on sportive performance, balance and injury risk in runners, 49 athletes will include in the study. The myofascial application group (n=26)will receive 12 sessions of 6-weekly lower extremity posterior muscle therapy. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Runt
What is being tested?: Myofascial therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Sep 2021to 1 Sep 2022
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Have a running history of more than 3 months
Be between 18 and 45 years old
Being a healthy individual without chronic disease
No acute injury affecting the lower extremity
Running at least 5 km a week
Willingness to participate in the research

Who cannot join

Pregnancy or suspected pregnancy
Use of alcohol or active substance
Having another ongoing treatment process
Having a history of surgery on the lower extremity
Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Backtofit
Istanbul, Sarıyer, 34460

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Myofascial Release Technique on Sportive Performance, Balance and Injury Risk in Runners.

Read the detailed description

Running is a sport that involves repetitive movement and is particularly vulnerable to injury in the lower extremities. Myofascial release, on the other hand, is a manual method that is effective in increasing blood and oxygen permeability between tissues, renewing the tissue, protecting it from injury and increasing performance. The aim of our study is to investigate the effect of Myofascial application on sportive performance balance and injury risk in runners. The study will carry out on runners with a 3-month running history. Myofascial application group (n=26) and control group (n=23) will divide into two groups as randomized controlled. My Jump 2 App, Y balance test and Functional Movement Analysis (FMS) will use as assessment methods. The myofascial application group will receive 12 sessions of 6 weeks of therapy for the lower extremity posterior group muscles. The control group will continue the routine exercise program.

Conditions: Runt
Being tested: Myofascial therapy
Keywords: myofascial release, run, performance, balance, injury risk, fascia
Medical subject headings: Dwarfism

What participants receive

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

Myofascial therapyOther
Also called Cross-hand technique
Running is a sport that involves repetitive movement and is particularly vulnerable to injury in the lower extremities. Myofascial release, on the other hand, is a manual method that is effective in increasing blood and oxygen permeability between tissues, renewing the tissue, protecting it from injury and increasing performance. The aim of our study is to investigate the effect of Myofascial therapy on sportive performance balance and injury risk in runners. The study will carry out on runners with a 3-month running history.

Study groups in NCT05392153
Study group	Role	What they receive
Myofascial therapy group	Experimental	The myofascial therapy group (n=26) will receive 12 sessions of 6-weekly lower extremity posterior muscle myofascial therapy. Receives: Other: Myofascial therapy
Control group	No intervention	The control group (n=23) will not receive lower extremity posterior muscle myofascial therapy. They will continue the routine exercise program.

What is being measured

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

The effect of myofascial release technique on sportive performance
Vertical jump test (My jump 2 App.) is a valid, reliable, and useful tool for measuring vertical jump in recreationally active adults
Measured: Baseline and 6th week

Secondary outcomes (2)

The effect of myofascial release technique on balance
Y balance test is a functional movement screening device commonly used to predict the risks of injury in athletes.
Measured: Baseline and 6th week
The effect of myofascial release technique on injury risk
The Functional Movement Screen (FMS) was designed to identify functional movement deficits and asymmetries that may be predictive of general musculoskeletal conditions and injuries, with an ultimate goal of being able to modify the identified movement deficits through individualized exercise prescription.
Measured: Baseline and 6th week

Timeline

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

1 Sep 20211 Sep 2022

First posted26 May 2022
Study start1 Sep 2021
Primary completion1 Sep 2021
Study completion1 Sep 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for RuntStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 49 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05392153
Sponsor's protocol ID: E-10840098-772.02-2678
Status last verified: Apr 2022
First submitted: 10 May 2022
Last updated: 26 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hreljac A. Impact and overuse injuries in runners. Med Sci Sports Exerc. 2004 May;36(5):845-9. doi: 10.1249/01.mss.0000126803.66636.dd.
PubMed 15126720
Adstrum S, Hedley G, Schleip R, Stecco C, Yucesoy CA. Defining the fascial system. J Bodyw Mov Ther. 2017 Jan;21(1):173-177. doi: 10.1016/j.jbmt.2016.11.003. Epub 2016 Nov 16.
PubMed 28167173
Sullivan KM, Silvey DB, Button DC, Behm DG. Roller-massager application to the hamstrings increases sit-and-reach range of motion within five to ten seconds without performance impairments. Int J Sports Phys Ther. 2013 Jun;8(3):228-36.
PubMed 23772339
LeBauer A, Brtalik R, Stowe K. The effect of myofascial release (MFR) on an adult with idiopathic scoliosis. J Bodyw Mov Ther. 2008 Oct;12(4):356-63. doi: 10.1016/j.jbmt.2008.03.008. Epub 2008 Jun 4.
PubMed 19083694
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
PubMed 25603749
Chaudhry H, Schleip R, Ji Z, Bukiet B, Maney M, Findley T. Three-dimensional mathematical model for deformation of human fasciae in manual therapy. J Am Osteopath Assoc. 2008 Aug;108(8):379-90. doi: 10.7556/jaoa.2008.108.8.379.
PubMed 18723456
Schleip R, Findley TW, Chaitow L, Huijing PA. Review of Fascia: The Tensional Network of the Human Body. 3. Baskı, E-book: Churchill Livingstone, 2012.
Emery CA, Cassidy JD, Klassen TP, Rosychuk RJ, Rowe BB. Development of a clinical static and dynamic standing balance measurement tool appropriate for use in adolescents. Phys Ther. 2005 Jun;85(6):502-14.
PubMed 15921472
Shumway-Cook A, Horak FB. Assessing the influence of sensory interaction of balance. Suggestion from the field. Phys Ther. 1986 Oct;66(10):1548-50. doi: 10.1093/ptj/66.10.1548. No abstract available.
PubMed 3763708
Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
PubMed 22892416
Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.
PubMed 21509114
Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.
PubMed 18226664
Landis SE, Baker RT, Seegmiller JG. NON-CONTACT ANTERIOR CRUCIATE LIGAMENT AND LOWER EXTREMITY INJURY RISK PREDICTION USING FUNCTIONAL MOVEMENT SCREEN AND KNEE ABDUCTION MOMENT: AN EPIDEMIOLOGICAL OBSERVATION OF FEMALE INTERCOLLEGIATE ATHLETES. Int J Sports Phys Ther. 2018 Dec;13(6):973-984.
PubMed 30534463
Philp F, Blana D, Chadwick EK, Stewart C, Stapleton C, Major K, Pandyan AD. Study of the measurement and predictive validity of the Functional Movement Screen. BMJ Open Sport Exerc Med. 2018 May 7;4(1):e000357. doi: 10.1136/bmjsem-2018-000357. eCollection 2018.
PubMed 29765700
Kraemer WJ, Mazzetti SA, Nindl BC, Gotshalk LA, Volek JS, Bush JA, Marx JO, Dohi K, Gomez AL, Miles M, Fleck SJ, Newton RU, Hakkinen K. Effect of resistance training on women's strength/power and occupational performances. Med Sci Sports Exerc. 2001 Jun;33(6):1011-25. doi: 10.1097/00005768-200106000-00022.
PubMed 11404668

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Runt trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Myofascial Release Technique on Sportive Performance, Balance and Injury Risk in Runners.
ClinicalTrials.gov ID: NCT05392153
Acronym / sponsor ID: E-10840098-772.02-2678
Conditions: Runt
Keywords: myofascial release, run, performance, balance, injury risk, fascia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 49 participants (estimated)
Lead sponsor: Istanbul Medipol University HospitalUniversity, hospital or other
Study start: 1 Sep 2021 (actual)
Primary completion: 1 Sep 2021 (actual)
Study completion: 1 Sep 2022 (estimated)
First posted: 26 May 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Myofascial therapy group	Experimental	Other: Myofascial therapyThe myofascial therapy group (n=26) will receive 12 sessions of 6-weekly lower extremity posterior muscle myofascial therapy.
Control group	No intervention	–The control group (n=23) will not receive lower extremity posterior muscle myofascial therapy. They will continue the routine exercise program.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Have a running history of more than 3 months
Be between 18 and 45 years old
Being a healthy individual without chronic disease
No acute injury affecting the lower extremity
Running at least 5 km a week

Key exclusion criteria (5 listed)

Pregnancy or suspected pregnancy
Use of alcohol or active substance
Having another ongoing treatment process
Having a history of surgery on the lower extremity
Refusal to participate in the study

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
Myofascial therapyAlso: Cross-hand techniqueRunning is a sport that involves repetitive movement and is particularly vulnerable to injury in the lower extremities. Myofascial release, on the other hand, is a manual method that is effective in increasing blood and oxygen permeability between tissues, renewing the tissue, protecting it from injury and increasing performance. The aim of our study is to investigate the effect of Myofascial therapy on sportive performance balance and injury risk in runners. The study will carry out on runners with a 3-month running history.	Other	Myofascial therapy group

Primary outcome

The effect of myofascial release technique on sportive performance
Time frame: Baseline and 6th week
Vertical jump test (My jump 2 App.) is a valid, reliable, and useful tool for measuring vertical jump in recreationally active adults

2 secondary outcomes

The effect of myofascial release technique on balance
Time frame: Baseline and 6th week
The effect of myofascial release technique on injury risk
Time frame: Baseline and 6th week

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
Background: PubMed 15126720Hreljac A. Impact and overuse injuries in runners. Med Sci Sports Exerc. 2004 May;36(5):845-9. doi: 10.1249/01.mss.0000126803.66636.dd.
Background: PubMed 28167173Adstrum S, Hedley G, Schleip R, Stecco C, Yucesoy CA. Defining the fascial system. J Bodyw Mov Ther. 2017 Jan;21(1):173-177. doi: 10.1016/j.jbmt.2016.11.003. Epub 2016 Nov 16.
Background: PubMed 23772339Sullivan KM, Silvey DB, Button DC, Behm DG. Roller-massager application to the hamstrings increases sit-and-reach range of motion within five to ten seconds without performance impairments. Int J Sports Phys Ther. 2013 Jun;8(3):228-36.
Background: PubMed 19083694LeBauer A, Brtalik R, Stowe K. The effect of myofascial release (MFR) on an adult with idiopathic scoliosis. J Bodyw Mov Ther. 2008 Oct;12(4):356-63. doi: 10.1016/j.jbmt.2008.03.008. Epub 2008 Jun 4.
Background: PubMed 25603749Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
Background: PubMed 18723456Chaudhry H, Schleip R, Ji Z, Bukiet B, Maney M, Findley T. Three-dimensional mathematical model for deformation of human fasciae in manual therapy. J Am Osteopath Assoc. 2008 Aug;108(8):379-90. doi: 10.7556/jaoa.2008.108.8.379.
BackgroundSchleip R, Findley TW, Chaitow L, Huijing PA. Review of Fascia: The Tensional Network of the Human Body. 3. Baskı, E-book: Churchill Livingstone, 2012.
Background: PubMed 15921472Emery CA, Cassidy JD, Klassen TP, Rosychuk RJ, Rowe BB. Development of a clinical static and dynamic standing balance measurement tool appropriate for use in adolescents. Phys Ther. 2005 Jun;85(6):502-14.
Background: PubMed 3763708Shumway-Cook A, Horak FB. Assessing the influence of sensory interaction of balance. Suggestion from the field. Phys Ther. 1986 Oct;66(10):1548-50. doi: 10.1093/ptj/66.10.1548. No abstract available.
Background: PubMed 22892416Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
Background: PubMed 21509114Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.
Background: PubMed 18226664Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.
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.

Seval Kutlutürk Yıkılmaz, PhD study chair

Medipol University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial therapy in people with Runt, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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 Turkey (Türkiye). 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?

Results are not available in the source record.

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?

The effect of myofascial release technique on sportive performance (time frame: Baseline and 6th week). 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 NCT05392153, which also lists 22 linked publications.

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 26 May 2022.