Muscle TearTHEALinMJNCT06812611
Effects of High Intensity Laser Therapy in Muscle Injuries
A study testing High Energy Laser Group and Exercise in people with Muscle Tear, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Muscle Tear
- What is being tested?
- High Energy Laser Group and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico di Bari
Bari, 70124
Angela Notarnicola, 0805592938, angelanotarnicola@yahoo.it
Ilaria Covelli, MD PhD, +39 0805592938, ilariacovelli@yahoo.it
About this study
Official title: Effects of High Intensity Laser Therapy In Lower Limb Muscle Injuries: a Randomized Controlled Study
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).
Read the detailed description
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.
- Conditions
- Muscle Tear
- Being tested
- High Energy Laser Group, Exercise
- Keywords
- laser, high energy, limb, muscle tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Energy Laser GroupDevice
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.
ExerciseOther
Daily exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: From enrollment to 3 weeks and 3 months
Secondary outcomes (3)
Size of the lesion
ultrasound evaluation of the size of the muscle lesion
Measured: From enrollment to 3 weeks and 3 months
Frequency of relapses
Onset of new muscle injury
Measured: From enrollment to 3 weeks and 3 months
Return to sport activity
Number of days to return to play
Measured: From enrollment to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812611
- Sponsor's protocol ID
- THEALinMJ
- Acronym
- THEALinMJ
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38160343Medeiros 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.
PubMed 31991284Askling 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.
PubMed 24620041
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Laser Therapy In Lower Limb Muscle Injuries: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06812611
- Acronym / sponsor ID
- THEALinMJ / THEALinMJ
- Conditions
- Muscle Tear
- Keywords
- laser, high energy, limb, muscle tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| High Energy Laser Group | Experimental | Device: High Energy Laser Group, Other: ExerciseThe 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 Group | Active comparator | Other: ExerciseAll 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
- congenital anomalies of the lower limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Energy Laser GroupThe 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 |
| ExerciseDaily exercise | Other | Exercise Group, High Energy Laser Group |
Primary outcome
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."
3 secondary outcomes
Size of the lesion
Time frame: From enrollment to 3 weeks and 3 months
Frequency of relapses
Time frame: From enrollment to 3 weeks and 3 months
Return to sport activity
Time frame: From enrollment to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 38160343Scaturro 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.
- Background: PubMed 31991284Medeiros 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.
- Background: PubMed 24620041Askling 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Energy Laser Group and Exercise in people with Muscle Tear, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Notarnicola, M.D.Ph.D. (0805592938, angelanotarnicola@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery of pain (time frame: From enrollment to 3 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812611, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.