Rehabilitation of Partially Injured Hamstring Muscles

May 30, 2024 updated by: Kamal Hadib Abdulridha, Universidad de Zaragoza

The Effect of Therapeutic Exercises and Ultrasound for Rehabilitation of Partially Injured Hamstring Muscles in Elite Football Players: a Study Protocol for a Randomized Controlled Trial

The aim of this study protocol is to describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles on elite football players.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hamstring muscle injuries are common among highly active individuals. Modern Football is a challenging sport characterized by extremely dynamic and cyclical game motions including numerous bouts of high-speed movements such as accelerating, jumping, and change in direction, all of which are carried out at a high level of physical and technical difficulty. The most common reason for hamstring muscle injury is high-performance intensity. In addition, neuromuscular fatigue, athlete aging, low muscle strength, and hamstring muscle flexibility are also risk factors for hamstring muscle injuries. On the other hand, the main causes of repetition injury to the same muscle are the presence of a previous injury, the size of the muscle tear and the lessening of the long head muscle bundles of the biceps femoris

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kamal H Abdulridha, PhD Studet
  • Phone Number: +34627114493
  • Email: 832595@unizar.es

Study Locations

  • Iraq
      • Baghdad, Iraq, 10070
        • University of Baghdad/ college of Physical Education and Sports Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Players from the eight clubs in the Iraqi Football League

  • Partially strained hamstring muscle pain when training football or playing a match, identified as:

    a. Player reported sudden pain in hamstring muscle c. Without any additional ailment.

  • Based on the clinical signs and symptoms, defined as:

    1. Localised pain when palpating of hamstring muscle
    2. Localised pain from at least one of the following activities: The Extender, The Diver, and The Glider.
  • MRI-confirmed of partially injured hamstring
  • Available for follow-up

Exclusion criteria:

  • Players with other injuries apart from hamstring injuries
  • Players with a recent six-month history of a verified or suspected hamstring injury in the same leg.
  • injured players who are already taking part in another rehabilitation program
  • General contraindications for MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: evaluate the effect of using therapeutic exercises and ultrasound
evaluate the effect of using therapeutic exercises and ultrasound for the rehabilitation of partially injured hamstring muscles.
Other: Therapeutic Exercises and Ultrasound
describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles
Experimental: analyse its effectiveness on the speedy healing
analyse its effectiveness on the speedy healing, which will be defined through some physical variables (hamstring muscle strength, the electrical activity of hamstring muscles) and pain perception.
Other: Therapeutic Exercises and Ultrasound
describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to return to play
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
The primary outcomes will be speedy healing, that is, the amount of time needed to recover from an injury in order to fully participate in team training and be available for match selection by the medical staff based on five standardized criteria: 1. no pain on palpation 2. pain free Range of Motion (ROM) 3. Muscular strength evaluation 4. Symptom-free completion of rehabilitation program 5. A specific running test.
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hamstring muscle strength
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
Force Sensor from Chronojump. Is an sensor measure of to conduct isometric knee flexion strength testing at two distinct angles: 15° and 90° of knee flexion.
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
Muscle bio potential signals
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
The Electromyogram (EMG) is collected at 1000 Hz with MyoTrace™ 400 . Is a versatile portable handheld, Self-adhesive silver chloride dual snap electrodes for surface attachment will be placed on the leg muscles. The MyoTrace 400 handheld transmitter.
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
Degree of pain
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
Pain visual analog scale (VAS). It is a unidimensional measure of hamstrings pain intensity that consists of a straight horizontal line of fixed length (typically 100 mm) that is graduated. The ends, which were towards the direction of left (worse) to right (best), defined the extreme boundaries of the parameter to be calculated (pain); the higher the score, the more severe the suffering.
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kamal H Abdulridha, PhD/Studet, Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Injured Hamstring Muscles

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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