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NCT Number: NCT07544004

Chitosan Phonophoresis With Recurrent Hamstring Strain in Athletes

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo Uneversity

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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.

Exclusion criteria

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
  • 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.

Treatment and study plan

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).

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulrahman Alwadei, MSc

CONTACT

[email protected]

+966565645057

Afaf Tahoon, PhD

CONTACT

+201015401783

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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