Effects of High Intensity Laser Therapy in Muscle Injuries

NCT06812611 | Not Yet Recruiting

• 1 other identifier: THEALinMJ
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Muscle Tear

Keywords

laser; high energy; limb; muscle tear

Outcome Measures

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."

  From enrollment to 3 weeks and 3 months

Secondary Outcomes (3)

• Size of the lesion

  From enrollment to 3 weeks and 3 months

• Frequency of relapses

  From enrollment to 3 weeks and 3 months

• Return to sport activity

  From enrollment to 3 months

Study Arms (2)

High Energy Laser Group

EXPERIMENTAL

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

Exercise Group

ACTIVE COMPARATOR

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

Interventions

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.

High Energy Laser Group

Exercise OTHER

Daily exercise

Exercise Group; High Energy Laser Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• no previous muscle injury in the last 6 months;
• signing of the written informed consent for participation in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Policlinico di Bari

Bari, 70124, Italy

Location

Related Publications (3)

• Scaturro D, de Sire A, Vitagliani F, Lo Nardo D, Tomasello S, Ammendolia A, Letizia Mauro G. Effectiveness of cryo plus ultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in footballers with muscle injuries: A prospective study. J Back Musculoskelet Rehabil. 2024;37(3):771-780. doi: 10.3233/BMR-230265.

  PMID: 38160343 BACKGROUND

• Medeiros DM, Aimi M, Vaz MA, Baroni BM. Effects of low-level laser therapy on hamstring strain injury rehabilitation: A randomized controlled trial. Phys Ther Sport. 2020 Mar;42:124-130. doi: 10.1016/j.ptsp.2020.01.006. Epub 2020 Jan 10.

  PMID: 31991284 BACKGROUND

• Askling CM, Tengvar M, Tarassova O, Thorstensson A. Acute hamstring injuries in Swedish elite sprinters and jumpers: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2014 Apr;48(7):532-9. doi: 10.1136/bjsports-2013-093214.

  PMID: 24620041 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Angela Notarnicola, M.D.Ph.D.

CONTACT

0805592938; angelanotarnicola@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-01

Locations

IT (1)