Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06812611

Effects of High Intensity Laser Therapy in Muscle Injuries

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In the acute phase, the current management of muscle injuries is essentially based on the PRICE protocol (protection, rest, ice, compression, elevation), although there are still no randomized clinical trials in the literature demonstrating its real effectiveness. Subsequently, the player undertakes rehabilitation with exercises and therapies aimed at resolving the edema, repairing the injury, strengthening the muscles and restoring athletic movements.

Biostimulations (laser therapy, diathermy, US, etc) are applied in muscle lesions for their analgesic and anti-inflammatory action, but to date there is a lack of adequate clinical evidence. The high energy laser has a great penetration force deep into the tissues and through its photochemical effects, increases mitochondrial oxidation and facilitates the formation of adenosine triphosphate (ATP), as well as inducing an increase in metabolism and blood circulation, with rapid absorption of edema and elimination of exudates. This induces an important biological action, causing muscle relaxation and inhibition of free nerve endings resulting in an immediate reduction in pain.

Preclinical studies have shown that physical therapies, such as high-energy laser therapy, improve muscle regeneration. On the other hand, to date few clinical studies have investigated the effects of biostimulations on muscle injuries. Medeiros et al. did not find benefits in the application of low energy laser in the treatment of muscle injuries, hypothesizing that a late application may have undermined the effects of biostimulation, which is fundamental in the first days of a late injury. Scaturro et al. , applying a combination of high energy laser and diathermy in association with rehabilitation treatment within 5 days of muscle injury, found positive effects on pain remission, return to sporting activity and the number of relapses. On the other hand, in this study, the contextual administration of two biostimulations (high energy laser and tecar therapy) does not allow us to discriminate the biological and clinical effects attributable to each of the two therapeutic methods.

Therefore, the aim of the present study is to investigate the effects of high intensity laser therapy in the treatment of lower limb muscle injuries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • instability or previous sprain of the ankle;
  • active neoplastic or infectious diseases;
  • contraindications to biostimulation;
  • congenital anomalies of the lower limbs.

Treatment and study plan

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

Daily exercise

Primary outcomes

  1. recovery of pain

    Time frame: From enrollment to 3 weeks and 3 months

    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."

Secondary outcomes

  1. Size of the lesion

    Time frame: From enrollment to 3 weeks and 3 months

    ultrasound evaluation of the size of the muscle lesion

  2. Frequency of relapses

    Time frame: From enrollment to 3 weeks and 3 months

    Onset of new muscle injury

  3. Return to sport activity

    Time frame: From enrollment to 3 months

    Number of days to return to play

Study contacts

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

Angela Notarnicola, M.D.Ph.D.

CONTACT

[email protected]

0805592938

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

Effects of High Intensity Laser Therapy In Lower Limb Muscle Injuries: a Randomized Controlled Study

Acronym: THEALinMJ

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
May 14, 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.

Published trials that share one or more normalized conditions with this study.