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Chitosan Phonophoresis With Recurrent Hamstring Strain in Athletes

Effectiveness of Chitosan Phonophoresis on Tissue Healing and Performance Related Outcomes in Athletes With Recurrent Hamstring Strain

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07544004
Enrollment
80
Registered
2026-04-22
Start date
2026-01-01
Completion date
2027-03-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hamstring Injury

Keywords

chitosan nanoparticles, hamstring strain

Brief 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 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.

Interventions

COMBINATION_PRODUCTCHITOSAN PHONOPHORESIS

All participants will receive a standardized, criterion-based hamstring rehab, 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_PRODUCTcham phonophoresis

All participants will receive a standardized, criterion-based hamstring rehab, after a session included therapeutic ultrasound using cham 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).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

Participants will be included in the study if they fulfil the following criteria: 1. 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 2. Aged 18-35 years 3. 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 4. Current injury onset within 3-10 days of enrollment. 5. 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 6. VISA-H score ≤ 75 at screening 7. Body mass index between 18.5 and 30.0 kg/m². 8. Able to walk independently without an assistive device.

Exclusion criteria

Participants will be excluded if they have any of the following: 1. History of hamstring tendon avulsion (complete or partial) or surgical repair in either limb. 2. Hamstring strain injury in the contralateral limb within the previous 12 months. 3. 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. 4. Neurological disorder affecting lower extremity motor or sensory function such as peripheral neuropathy, lumbar radiculopathy, or multiple sclerosis. 5. Known allergy or hypersensitivity to chitosan, chitin, or shellfish, identified by self-report on a standardized allergy screening questionnaire at enrollment 6. Active skin disease, open wounds, or dermatitis over the posterior thigh of the affected limb. 7. Corticosteroid injection to the ipsilateral hamstring within the previous 6 months 8. Systemic conditions impairing healing such as diabetes mellitus, immunosuppressive therapy, chronic kidney disease, autoimmune connective tissue disorders, or coagulation disorders. 9. 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.

Design outcomes

Primary

MeasureTime frameDescription
The Peetrons Classification SystembaselineThe 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 - Hamstringbaseline and 6 weeks post interventionThe 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 Testbaseline and 6 weeks post interventionThe Single-Leg Hamstring Bridge Test will be used to evaluate the effectiveness of rehabilitation protocols that reflect hamstring strength
Lower Extremity Functional Testbaseline and 6 weeks post interventionThe 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 Testbaseline and 6 weeks post interventionThe Active Knee Extension Test is excellent in symptomatic and healthy (ICC often ≥0.90), used with an inclinometer

Countries

Egypt

Contacts

STUDY_DIRECTORnasr abdelkader, PhD

cairo universoty

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026