Hamstring InjuryNCT07544004
Chitosan Phonophoresis With Recurrent Hamstring Strain in Athletes
A study testing CHITOSAN PHONOPHORESIS in people with Hamstring Injury, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- CHITOSAN PHONOPHORESIS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be included in the study if they fulfill the following criteria:
- Male recreational football players who participate in non-professional football training or matches for at least two sessions per week (each session ≥ 45 minutes) for at least the previous 12 months
- Aged 18-35 years
- Clinically diagnosed with a new episode of acute unilateral recurrent hamstring strain. Recurrent injury is defined as a new acute hamstring injury in the same limb and muscle group (biceps femoris, semitendinosus, or semimembranosus) as at least one previous hamstring strain that was professionally diagnosed, treated with rehabilitation, and after which the athlete returned to full participation. The previous injury must have occurred within the last 24 months
- Current injury onset within 3-10 days of enrollment.
- Current injury classified as Peetrons grade I or II on diagnostic musculoskeletal ultrasound performed within 7 days of enrollment by a single sonographer with at least 5 years of experience, using a 12-18 MHz linear probe in prone position (Peetrons, 2002; Heiss et al., 2025). The specific muscle involved, location within the muscle, and lesion volume (π/6 × L × W × D) will be documented at baseline
Show all 9Show fewer
- VISA-H score ≤ 75 at screening
- Body mass index between 18.5 and 30.0 kg/m².
- Able to walk independently without an assistive device.
Who cannot join
- Participants will be excluded if they have any of the following:
- History of hamstring tendon avulsion (complete or partial) or surgical repair in either limb.
- Hamstring strain injury in the contralateral limb within the previous 12 months.
- Concomitant lower extremity or lumbopelvic pathology that prevents safe completion of testing at maximal effort, including but not limited to knee ligament injury, meniscal injury, hip labral pathology, sacroiliac joint dysfunction, or lumbar disc herniation with radiculopathy.
- Neurological disorder affecting lower extremity motor or sensory function such as peripheral neuropathy, lumbar radiculopathy, or multiple sclerosis.
- Known allergy or hypersensitivity to chitosan, chitin, or shellfish, identified by self-report on a standardized allergy screening questionnaire at enrollment
Show all 10Show fewer
- Active skin disease, open wounds, or dermatitis over the posterior thigh of the affected limb.
- Corticosteroid injection to the ipsilateral hamstring within the previous 6 months
- Systemic conditions impairing healing such as diabetes mellitus, immunosuppressive therapy, chronic kidney disease, autoimmune connective tissue disorders, or coagulation disorders.
- Use of pharmacological agents or supplements with known effects on tissue healing (such as growth hormone, anabolic steroids, or collagen supplements) within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Afaf Tahoon, PhD contact
About this study
Official title: Effectiveness of Chitosan Phonophoresis on Tissue Healing and Performance Related Outcomes in Athletes With Recurrent Hamstring Strain
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.
Read the detailed description
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.
- Conditions
- Hamstring Injury
- Being tested
- CHITOSAN PHONOPHORESIS, SHAM PHONOPHORESIS
- Keywords
- Chitosan nanoparticles, Hamstring Strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHITOSAN PHONOPHORESISCombination 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).
SHAM PHONOPHORESISCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | exercise-based rehabilitation program + chitosan phonophoresis Receives: Combination Product: CHITOSAN PHONOPHORESIS |
| Control group | Sham comparator | exercise-based rehabilitation program + sham chitosan phonophoresis Receives: Combination Product: SHAM PHONOPHORESIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdulrahman saleh alwadei, Cairo University
- Investigators
- Nasr Abdelkader, PhD, Study director, Cairo universotyOsama Sayed, PhD, Study director, Cairo universoty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544004
- Sponsor's protocol ID
- chitosan with hamstring strain
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chitosan Phonophoresis on Tissue Healing and Performance Related Outcomes in Athletes With Recurrent Hamstring Strain
- ClinicalTrials.gov ID
- NCT07544004
- Acronym / sponsor ID
- chitosan with hamstring strain
- Conditions
- Hamstring Injury
- Keywords
- Chitosan nanoparticles, Hamstring Strain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: CHITOSAN PHONOPHORESISexercise-based rehabilitation program + chitosan phonophoresis |
| Control group | Sham comparator | Combination Product: SHAM PHONOPHORESISexercise-based rehabilitation program + sham chitosan phonophoresis |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male recreational football players who participate in non-professional football training or matches for at least two sessions per week (each session ≥ 45 minutes) for at least the previous 12 months
- Aged 18-35 years
- Clinically diagnosed with a new episode of acute unilateral recurrent hamstring strain. Recurrent injury is defined as a new acute hamstring injury in the same limb and muscle group (biceps femoris, semitendinosus, or semimembranosus) as at least one previous hamstring strain that was professionally diagnosed, treated with rehabilitation, and after which the athlete returned to full participation. The previous injury must have occurred within the last 24 months
- Current injury onset within 3-10 days of enrollment.
- Current injury classified as Peetrons grade I or II on diagnostic musculoskeletal ultrasound performed within 7 days of enrollment by a single sonographer with at least 5 years of experience, using a 12-18 MHz linear probe in prone position (Peetrons, 2002; Heiss et al., 2025). The specific muscle involved, location within the muscle, and lesion volume (π/6 × L × W × D) will be documented at baseline
Key exclusion criteria (10 listed)
- History of hamstring tendon avulsion (complete or partial) or surgical repair in either limb.
- Hamstring strain injury in the contralateral limb within the previous 12 months.
- Concomitant lower extremity or lumbopelvic pathology that prevents safe completion of testing at maximal effort, including but not limited to knee ligament injury, meniscal injury, hip labral pathology, sacroiliac joint dysfunction, or lumbar disc herniation with radiculopathy.
- Neurological disorder affecting lower extremity motor or sensory function such as peripheral neuropathy, lumbar radiculopathy, or multiple sclerosis.
- Known allergy or hypersensitivity to chitosan, chitin, or shellfish, identified by self-report on a standardized allergy screening questionnaire at enrollment
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 |
|---|---|---|
| CHITOSAN PHONOPHORESISAll 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). | Combination product | Intervention group |
| SHAM PHONOPHORESISAll 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). | Combination product | Control group |
Primary outcome
The Peetrons Classification System
Time frame: baseline
The system consists of four grades (from 0 to 3) which describe the structural integrity of the muscle as seen on diagnostic ultrasonography
Victorian Institute of Sport Assessment - Hamstring
Time frame: baseline and 6 weeks post intervention
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
Single-Leg Hamstring Bridge Test
Time frame: baseline and 6 weeks post intervention
The Single-Leg Hamstring Bridge Test will be used to evaluate the effectiveness of rehabilitation protocols that reflect hamstring strength
Lower Extremity Functional Test
Time frame: baseline and 6 weeks post intervention
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
Active Knee Extension Test
Time frame: baseline and 6 weeks post intervention
The Active Knee Extension Test is excellent in symptomatic and healthy (ICC often ≥0.90), used with an inclinometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Related trials for Hamstring Injury
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Recruiting
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
ACL - Anterior Cruciate Ligament Rupture
RecruitingObservational study
Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injury
Recruiting
Effects Of Criteria Versus Time-Based Rehabilitation On Return To Play In Football Players
Hamstring Muscle Strain
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.
Afaf Tahoon, PhD contact
Nasr Abdelkader, PhD study director
Cairo universoty
Osama Sayed, PhD study director
Cairo universoty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHITOSAN PHONOPHORESIS in people with Hamstring Injury, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 Jun 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Alwadei, MSc (+966565645057, khuz.abd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Peetrons Classification System (time frame: baseline). The study lists 5 primary outcomes in all. 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 15 Jun 2026.