An interventional study of High Energy Laser Group and Exercise in Muscle Tear, sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. Recruiting at 1 site in Italy. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Not applicable, Interventional, and Treatment
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).
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.
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari is the lead sponsor of 44 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
knee instability due to previous rupture of the knee ligaments;
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.
Device: High Energy Laser Group · Other: Exercise
All patients will receive a rehabilitation protocol of 5 weekly sessions lasting approximately 60 minutes, for approximately 3 weeks. During the early post-injury phases, the protocol will include isometric exercises to strengthen core stability. These exercises will each be performed for 3 sets of 30 seconds, although the number of sets and repetitions may vary depending on the athlete's response.
Other: Exercise
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.
Daily exercise
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
Size of the lesion
ultrasound evaluation of the size of the muscle lesion
Time frame: From enrollment to 3 weeks and 3 months
Frequency of relapses
Onset of new muscle injury
Time frame: From enrollment to 3 weeks and 3 months
Return to sport activity
Number of days to return to play
Time frame: From enrollment to 3 months
Plan to share: Undecided
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari