Effects of High Intensity Laser Therapy in Muscle Injuries

ConditionMuscle Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

About this trial

Muscle injuries are frequent traumatic events in daily life, particularly during sports. In sports, their incidence varies from 10% to 55% of total injuries. According to the Mueller Wohlfart classification, muscle injuries are classified into direct traumatic injuries (contusion-laceration) and indirect traumatic injuries, which are further divided into non-structural injuries (grade I and II) and structural injuries. Structural lesions are further divided into partial muscle lesions (grade III): 3 A, minor partial lesion, i.e. lesion of one or more primary bundles with a secondary bundle; 3 B, moderate partial lesion, i.e. lesion of at least one secondary bundle and with a rupture area \< 50% of the muscle surface; and (sub)total muscle injury (grade IV).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

presence of a grade III A muscle lesion of the lower limbs, according to the Mueller-Wohlfart classification, confirmed by ultrasound examination and occurred during sporting activity at least 5 days before inclusion in the study;

no previous muscle injury in the last 6 months;

signing of the written informed consent for participation in the study.

Disqualifiers

previous muscle injuries or bone fractures of the lower limbs in the last 6 months;

knee instability due to previous rupture of the knee ligaments;

active neoplastic or infectious diseases;

contraindications to biostimulation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Energy Laser Group

    Device

    The multimodal high energy laser therapy treatment with thermal control (THEAL) will be delivered with an Ixyon XP device (Mectronic, Bergamo, Italy) which allows the delivery of 4 wavelengths (650 nm, 810 nm, 980 nm and 1064 nm), with continuous and pulsed mode, average power up to 30 W, administering 10 sessions every other day. The patients will simultaneously carry out the rehabilitation treatment exercises, as was expected in the control group.

  • Exercise

    Other intervention

    Daily exercise

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: High Energy Laser GroupExperimental treatment 2 interventions
Group B: Exercise GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

recovery of pain

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Time frame
From enrollment to 3 weeks and 3 months

Secondary outcomes

1

Size of the lesion

ultrasound evaluation of the size of the muscle lesion

Time frame
From enrollment to 3 weeks and 3 months
2

Frequency of relapses

Onset of new muscle injury

Time frame
From enrollment to 3 weeks and 3 months
3

Return to sport activity

Number of days to return to play

Time frame
From enrollment to 3 months

Other outcomes

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