Hamstring InjuryNCT04290065
Miodural Bridge Stretching in Posture Modification in Professional Footballers
A study testing Manual therapy in people with Hamstring Injury, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Fatigue influences the kinematics of the knee. Decreasing the tone of the suboccipital musculature may decrease the tone of the knee flexors. Inhibition of the suboccipital musculature is used to improve ischiosural muscle tension. Read more about this study
- Who is it for?
- Ages 18 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- Manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 10 Jun 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 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Football players
- Male
- From 18 to 23 years old
- That have a federation file in 3rd division in the Region of Murcia
- That you don't have any acute lesions at the time of the study.
Who cannot join
- Subjects that: present some relevant subacute or chronic pathology that may have a direct impact on the processes or structures related to the study who have neurological problems or related to the vestibular system
- That receive a specific Physiotherapy training on any of the study regions
- Not sign the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Intervention by Stretching the Miodural Bridge in the Modification of Posture in Professional Soccer Players. A Randomized Clinical Study.
Fatigue influences the kinematics of the knee. Decreasing the tone of the suboccipital musculature may decrease the tone of the knee flexors. Inhibition of the suboccipital musculature is used to improve ischiosural muscle tension.
The main objective of the study is to evaluate the effectiveness of the stretching of the miodural bridge in the modification of the posture in professional soccer players of 3rd division.
Read more
Randomized clinical trial. 30 players will be randomized to the two study groups: experimental (technique of stretching technique of the miodural bridge) and control (without intervention). A blinded evaluator will perform three evaluations: pretreatment, post-treatment and follow-up. The study variables will be: modification of posture and weight distribution (plantar pressure platform). The sample distribution will be calculated using a Kolmogórov-Smirnov analysis. The changes after each evaluation will be analyzed with the t-student test of related samples and through an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
After stretching the miodural bridge, it is expected to see improvement in posture changes.
- Conditions
- Hamstring Injury
- Being tested
- Manual therapy
- Keywords
- Hamstring muscle, Soccer, Flexibility, Hip joint, Suboccipital muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
The patient will be lying supine, relaxed. The physiotherapist, located at the patient's head, will cover the occipital bone with one hand while the palm of the hand will rest on the lambdoid suture, and the fingers will be introduced into the suboccipital space. The other hand, with a glove, will be inserted into the patient's oral cavity, resting respectively the index and middle fingers, each in an upper dental hemiarchy, on the chewing face of the tooth. An axial traction will be carried out until the three tension barriers of equal size between them are overcome, in an estimated time between 1.50 and 3 minutes. All manual therapy sessions will be performed by the same physiotherapist, following the same protocol and under the same conditions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention will take place over a period of 4 weeks, with 2 weekly sessions, with an estimated execution time of 1.50 to 3 minutes each. A manual therapy technique of inhibition of the suboccipital musculature and an axial traction of the upper hemiarchy will be performed Receives: Other: Manual therapy |
| Control group | No intervention | Athletes included in the control group will not perform any intervention, continuing with their usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline posture modification after treatment and at month
An evaluation will be carried out with a pedometric platform. For the evaluation of plantar pressures, we use a plantar pressure platform (Podoprint® S10Pro model). This platform has 4,096 sensors, which allow a maximum pressure of 100 N / cm2 per sensor and has a sampling frequency of 150 Hz. All measurements will be made in accordance with international standards for anthropometric evaluation. All the evaluated players will adopt a relaxed and inert bipedal orthopedic position (arms held at the sides of the body, barefoot, with clothes that allowed to see the feet, legs and knees). With eyes open and looking at a fixed point, at a distance of 1.50 m for 20 seconds.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (1)
Change from baseline modification of the weight distribution after treatment and at month
An evaluation will be carried out with a pedometric platform, to assess the distribution of body weight after the intervention by stretching the Miodural Bridge. The unit of measure will be the percentage of weight in each of the evaluations
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start2 Mar 2020
- Primary completion20 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290065
- Sponsor's protocol ID
- POST
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention by Stretching the Miodural Bridge in the Modification of Posture in Professional Soccer Players. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04290065
- Acronym / sponsor ID
- POST
- Conditions
- Hamstring Injury
- Keywords
- Hamstring muscle, Soccer, Flexibility, Hip joint, Suboccipital muscles
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 28 Feb 2020 (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.
Fatigue influences the kinematics of the knee. Decreasing the tone of the suboccipital musculature may decrease the tone of the knee flexors. Inhibition of the suboccipital musculature is used to improve ischiosural muscle tension.
The main objective of the study is to evaluate the effectiveness of the stretching of the miodural bridge in the modification of the posture in professional soccer players of 3rd division.
Randomized clinical trial. 30 players will be randomized to the two study groups: experimental (technique of stretching technique of the miodural bridge) and control (without intervention). A blinded evaluator will perform three evaluations: pretreatment, post-treatment and follow-up. The study variables will be: modification of posture and weight distribution (plantar pressure platform). The sample distribution will be calculated using a Kolmogórov-Smirnov analysis. The changes after each evaluation will be analyzed with the t-student test of related samples and through an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
After stretching the miodural bridge, it is expected to see improvement in posture changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Manual therapyThe intervention will take place over a period of 4 weeks, with 2 weekly sessions, with an estimated execution time of 1.50 to 3 minutes each. A manual therapy technique of inhibition of the suboccipital musculature and an axial traction of the upper hemiarchy will be performed |
| Control group | No intervention | –Athletes included in the control group will not perform any intervention, continuing with their usual routine. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Football players
- Male
- From 18 to 23 years old
- That have a federation file in 3rd division in the Region of Murcia
- That you don't have any acute lesions at the time of the study.
Key exclusion criteria (3 listed)
- Subjects that: present some relevant subacute or chronic pathology that may have a direct impact on the processes or structures related to the study who have neurological problems or related to the vestibular system
- That receive a specific Physiotherapy training on any of the study regions
- Not sign the informed consent document
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 |
|---|---|---|
| Manual therapyThe patient will be lying supine, relaxed. The physiotherapist, located at the patient's head, will cover the occipital bone with one hand while the palm of the hand will rest on the lambdoid suture, and the fingers will be introduced into the suboccipital space. The other hand, with a glove, will be inserted into the patient's oral cavity, resting respectively the index and middle fingers, each in an upper dental hemiarchy, on the chewing face of the tooth. An axial traction will be carried out until the three tension barriers of equal size between them are overcome, in an estimated time between 1.50 and 3 minutes. All manual therapy sessions will be performed by the same physiotherapist, following the same protocol and under the same conditions. | Other | Experimental group |
Primary outcome
Change from baseline posture modification after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
An evaluation will be carried out with a pedometric platform. For the evaluation of plantar pressures, we use a plantar pressure platform (Podoprint® S10Pro model). This platform has 4,096 sensors, which allow a maximum pressure of 100 N / cm2 per sensor and has a sampling frequency of 150 Hz. All measurements will be made in accordance with international standards for anthropometric evaluation. All the evaluated players will adopt a relaxed and inert bipedal orthopedic position (arms held at the sides of the body, barefoot, with clothes that allowed to see the feet, legs and knees). With eyes open and looking at a fixed point, at a distance of 1.50 m for 20 seconds.
1 secondary outcome
Change from baseline modification of the weight distribution after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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 Manual therapy in people with Hamstring Injury, run by Investigación en Hemofilia y Fisioterapia 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 5 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: withdrawn, as of the sponsor's last update on 5 Sep 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline posture modification after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 5 Sep 2021.