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Chitosan Phonophoresis With Recurrent Hamstring Strain in Athletes

ConditionHamstring Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-35
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline
2

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

Time frame
baseline and 6 weeks post intervention
3

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

Time frame
baseline and 6 weeks post intervention
4

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

Time frame
baseline and 6 weeks post intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: