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The purpose of this randomized controlled trial is to evaluate and compare the effectiveness of adding chitosan phonophoresis as an adjunct to a rehabilitation-based exercise program compared to a rehabilitation-based exercise program with sham chitosan phonophoresis in athletes with recurrent hamstring strain injuries on the following outcomes: Hamstring-specific pain and function, Muscle strength and endurance, Lower extremity functions, Hamstring Flexibility symmetry and Hamstring injury healing score.
Hamstring injuries represent one of the most prevalent and recurrent soft tissue injuries in athletes, accounting for a significant percentage of time lost from training and competition across a variety of sports disciplines. These injuries encompass a spectrum of diagnoses, including muscle strains, proximal tendon avulsions, tendinopathies, and referred posterior thigh pain. The prevalence of recurrent hamstring strain injuries varies widely in studies, ranging from about 12% to as high as 63%. On average, recurrent hamstring strains account for around 26% of all hamstring injuries in sports such as Australian football, soccer, and rugby.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | exercise-based rehabilitation program + chitosan phonophoresis |
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| Control group | Sham Comparator | exercise-based rehabilitation program + sham chitosan phonophoresis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHITOSAN PHONOPHORESIS | Combination Product | All participants will receive a standardized, criterion-based hamstring rehabilitation, after a session included therapeutic ultrasound using chitosan phonophoresis. Each category contained two different exercises to offer more variability. The two categories will be trained alternately. All exercises will be organized in five or six progressive levels with increasing physical and cognitive difficulty, and will be required to be performed in order (from 1 to 5/6). The exercises start on the first level and move to the next one when exercises are executed with a proper technique, as assessed by the therapist. The program takes about 15-20 minutes to complete after familiarization (3 sessions/week, clinic-supervised, 6 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| The Peetrons Classification System | The system consists of four grades (from 0 to 3) which describe the structural integrity of the muscle as seen on diagnostic ultrasonography | baseline |
| Victorian Institute of Sport Assessment - Hamstring | The Victorian Institute of Sport Assessment - Hamstring is a self-administered questionnaire developed to quantify the severity of symptoms, functional limitations, and sporting disability associated with hamstring injuries | baseline and 6 weeks post intervention |
| Single-Leg Hamstring Bridge Test | The Single-Leg Hamstring Bridge Test will be used to evaluate the effectiveness of rehabilitation protocols that reflect hamstring strength | baseline and 6 weeks post intervention |
| Lower Extremity Functional Test | The Lower Extremity Functional Test is performance-based test designed to assess athletic fitness, fatigue resistance, agility, speed, and neuromuscular control of the lower limbs | baseline and 6 weeks post intervention |
| Active Knee Extension Test | The Active Knee Extension Test is excellent in symptomatic and healthy (ICC often ≥0.90), used with an inclinometer | baseline and 6 weeks post intervention |
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Inclusion Criteria:
Participants will be included in the study if they fulfill the following criteria:
Exclusion Criteria:
Participants will be excluded if they have any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdulrahman Alwadei, MSc | Contact | +966565645057 | khuz.abd@hotmail.com | |
| Afaf Tahoon, PhD | Contact | +201015401783 |
| Name | Affiliation | Role |
|---|---|---|
| Nasr Abdelkader, PhD | Cairo universoty | Study Director |
| Osama Sayed, PhD | Cairo universoty | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo Uneversity | Cairo | Egypt |
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This study is randomised, parallel, controlled clinical trial with two intervention arms. Participants with chronic hamstring strain will be randomly allocated to one of two groups recieving chitosan phonophoresis or sham phonophoresis and same based rehabilitation program.
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| SHAM PHONOPHORESIS | Combination Product | All participants will receive a standardized, criterion-based hamstring rehabilitation, after a session included therapeutic ultrasound using sham phonophoresis. Each category contained two different exercises to offer more variability. The two categories will be trained alternately. All exercises will be organized in five or six progressive levels with increasing physical and cognitive difficulty, and will be required to be performed in order (from 1 to 5/6). The exercises start on the first level and move to the next one when exercises are executed with a proper technique, as assessed by the therapist. The program takes about 15-20 minutes to complete after familiarization (3 sessions/week, clinic-supervised, 6 weeks). |
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