Chitosan Phonophoresis With Recurrent Hamstring Strain in Athletes

NCT07544004 | Enrolling By Invitation

• 1 other identifier: chitosan with hamstring strain
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hamstring Injury

Keywords

chitosan nanoparticles; hamstring strain

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

exercise-based rehabilitation program + chitosan phonophoresis

Combination Product: CHITOSAN PHONOPHORESIS

Control group

SHAM COMPARATOR

exercise-based rehabilitation program + sham chitosan phonophoresis

Combination Product: cham phonophoresis

Interventions

cham phonophoresis COMBINATION_PRODUCT

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).

Control group

CHITOSAN PHONOPHORESIS COMBINATION_PRODUCT

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be included in the study if they fulfil 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Uneversity

Cairo, Egypt

Location

Related Links

• references list

Study Officials

• nasr abdelkader, PhD

  cairo universoty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

EG (1)