Rotator Cuff TearsNCT07568288
The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair.
A study testing High intensity laser therapy in people with Rotator Cuff Tears, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) as an adjunct to conventional rehabilitation in patients undergoing arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- High intensity laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2029
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthroscopic rotator cuff repair of one shoulder for partial or full-thickness tear
- Willingness to provide written informed consent
- Age between 30 and 70 years
- Pain intensity greater than 40/100 on the Visual Analog Scale
Who cannot join
- Psychiatric disorders
- Cognitive impairment
- Rheumatic diseases or Fibromyalgia
- Vascular diseases
- Neoplastic diseases
- Infectious diseases
Show all 21Show fewer
- Neurological disorders
- Hemophilia or bleeding diathesis
- Use of anticoagulant therapy
- Presence of a pacemaker
- History of epileptic seizures
- Pregnancy or breastfeeding
- Skin lesions or abrasions at the laser application site
- Known hypersensitivity to laser therapy or photosensitization
- Use of photosensitizing medications
- Tattoo in the treatment area
- Steroid injections in the target area within the previous 2-3 weeks
- Recent trauma or injury
- Suspected conditions in which deep tissue heating is contraindicated
- Use of analgesic or anti-inflammatory medications during the study period
- Positive status for human immunodeficiency virus infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) as an adjunct to conventional rehabilitation in patients undergoing arthroscopic rotator cuff repair.
Despite surgical repair, patients frequently experience postoperative pain, limited range of motion, and delayed functional recovery. Conventional physiotherapy represents the standard of care; however, additional strategies may be needed to optimize outcomes. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects, but its effectiveness in the postoperative setting remains unclear.
Read more
Participants will be randomly allocated to one of two groups: an experimental group receiving HILT in addition to conventional physiotherapy, and a control group receiving sham laser therapy combined with the same rehabilitation program. Both groups will undergo standardized rehabilitation sessions including therapeutic exercise.
The primary outcome is pain intensity, measured using the Visual Analog Scale. Secondary outcomes include shoulder range of motion (active and passive), muscle strength, functional status assessed with the Constant-Murley Score, and patient-reported disability and quality of life measured using the Shoulder Pain and Disability Index and the Quick Disabilities of the Arm, Shoulder and Hand.
Assessments will be conducted at baseline (at the start of rehabilitation), during the intervention period after the fourth (T1), seventh (T2), and tenth (T3) physiotherapy sessions, and at follow-up at 4 months.
- Conditions
- Rotator Cuff Tears
- Being tested
- High intensity laser therapy, Sham laser therapy
- Keywords
- Arthroscopic rotator cuff repair, Rotator cuff repair, laser therapy, High intensity laser therapy, Rehabilitation, Shoulder pain
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laser therapyDevice
High-intensity laser therapy (HILT) will be administered using the HIRO TT device (ASA s.r.l., Italy), based on a solid-state Nd:YAG laser source with near-infrared emission at a wavelength of 1064 nm.
The treatment protocol consists of 10 sessions delivered on alternate days. Each session will last 60 minutes and will include 15 minutes of laser therapy followed by 45 minutes of conventional physiotherapy.
Laser therapy will be applied to two areas of 10 × 10 cm each, located at the anterolateral and posterior aspects of the shoulder. The treatment will be delivered using a pulsed emission with a frequency of 15 Hz, a total energy of 1000 J, and an energy density of 5 J/cm². The mean power will range between 6 and 10.5 W, with a peak power between 1 and 3 kW, for a total application time of 8 minutes and 30 seconds.
Sham laser therapyOther
The sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group.
The same anatomical areas (two treatment areas of 10 × 10 cm located at the anterolateral and posterior aspects of the shoulder) will be targeted, with identical session duration and patient positioning.
During sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| High level laser therapy group | Experimental | High-intensity laser therapy (HILT) will be administered using the HIRO TT device (ASA s.r.l., Italy), based on a solid-state Nd:YAG laser source with near-infrared emission at a wavelength of 1064 nm.
The treatment protocol consists of 10 sessions delivered on alternate days. Each session will last 60 minutes and will include 15 minutes of laser therapy followed by 45 minutes of conventional physiotherapy.
Laser therapy will be applied to two areas of 10 × 10 cm each, located at the anterolateral and posterior aspects of the shoulder. The treatment will be delivered using a pulsed emission with a frequency of 15 Hz, a total energy of 1000 J, and an energy density of 5 J/cm². The mean power will range between 6 and 10.5 W, with a peak power between 1 and 3 kW, for a total application time of 8 minutes and 30 seconds. Receives: Device: High intensity laser therapy |
| Sham laser therapy group | Sham comparator | The sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group.
The same anatomical areas (two treatment areas of 10 × 10 cm located at the anterolateral and posterior aspects of the shoulder) will be targeted, with identical session duration and patient positioning.
During sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect. Receives: Other: Sham laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The VAS consists of a 100-mm horizontal line anchored by two descriptors: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants will be asked to mark a point on the line corresponding to their perceived level of pain. The score will be determined by measuring the distance in millimeters from the left end of the line to the patient's mark, with higher scores indicating greater pain intensity.
Measured: after 3 weeks
Secondary outcomes (7)
Visual Analogue Scale
The VAS consists of a 100-mm horizontal line anchored by two descriptors: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants will be asked to mark a point on the line corresponding to their perceived level of pain. The score will be determined by measuring the distance in millimeters from the left end of the line to the patient's mark, with higher scores indicating greater pain intensity.
Measured: Baseline, after 1 week, after 2 weeks, after 4 months follow-up
Passive Range of Motion
Passive shoulder range of motion (ROM) will be assessed using a digital goniometer following standardized measurement procedures. Movements evaluated will include shoulder flexion, abduction, internal rotation and external rotation at 90° of abduction, and external rotation at 0° of abduction. Measurements will be performed with the patient in the supine position. For each movement, three repetitions will be recorded and the mean value will be used for analysis. Results will be expressed in degrees.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Active Range of Motion
Active shoulder range of motion (ROM) will be assessed using a digital goniometer following standardized measurement procedures. Movements evaluated will include shoulder flexion, abduction, and external rotation at 0° of abduction. Measurements will be performed with the patient in a standing position. For each movement, three repetitions will be recorded and the mean value will be used for analysis. Results will be expressed in degrees.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Muscle strength: Handheld dynamometer
Shoulder muscle strength will be assessed using a handheld digital dynamometer following standardized and reproducible testing positions. Isometric strength will be measured for shoulder abduction, internal rotation, and external rotation. Internal and external rotation will be evaluated with the patient in a seated position, with the arm at 0° and 90° of abduction in the scapular plane. Shoulder abduction will be assessed with the arm positioned at 45° of abduction.
For each movement, three maximal isometric contractions of 5 seconds will be performed, with 30 seconds of rest between trials. The highest value recorded will be used for analysis. Results will be expressed in kilograms.
Measured: after 3 weeks and after 4 months follow-up
Function: Constant-Murley Score
Shoulder function will be assessed using the Constant-Murley Score (CMS), a composite scale that evaluates pain, activities of daily living, range of motion, and muscle strength. The total score ranges from 0 to 100, with higher scores indicating better shoulder function.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Disability: Shoulder Pain Disability Index
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI), a self-administered questionnaire composed of 13 items divided into two subscales assessing pain and disability. The total score ranges from 0 to 100, with higher scores indicating greater pain and functional impairment.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Disability: Quick Disability of the Arm, Shoulder and Hand
Upper limb disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH), a self-administered questionnaire composed of 11 items rated on a Likert scale. The total score ranges from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568288
- Sponsor's protocol ID
- LASER_SHOULDER
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07568288
- Acronym / sponsor ID
- LASER_SHOULDER
- Conditions
- Rotator Cuff Tears
- Keywords
- Arthroscopic rotator cuff repair, Rotator cuff repair, laser therapy, High intensity laser therapy, Rehabilitation, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 5 May 2026 (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.
This randomized controlled trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) as an adjunct to conventional rehabilitation in patients undergoing arthroscopic rotator cuff repair.
Despite surgical repair, patients frequently experience postoperative pain, limited range of motion, and delayed functional recovery. Conventional physiotherapy represents the standard of care; however, additional strategies may be needed to optimize outcomes. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects, but its effectiveness in the postoperative setting remains unclear.
Participants will be randomly allocated to one of two groups: an experimental group receiving HILT in addition to conventional physiotherapy, and a control group receiving sham laser therapy combined with the same rehabilitation program. Both groups will undergo standardized rehabilitation sessions including therapeutic exercise.
The primary outcome is pain intensity, measured using the Visual Analog Scale. Secondary outcomes include shoulder range of motion (active and passive), muscle strength, functional status assessed with the Constant-Murley Score, and patient-reported disability and quality of life measured using the Shoulder Pain and Disability Index and the Quick Disabilities of the Arm, Shoulder and Hand.
Assessments will be conducted at baseline (at the start of rehabilitation), during the intervention period after the fourth (T1), seventh (T2), and tenth (T3) physiotherapy sessions, and at follow-up at 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High level laser therapy group | Experimental | Device: High intensity laser therapyHigh-intensity laser therapy (HILT) will be administered using the HIRO TT device (ASA s.r.l., Italy), based on a solid-state Nd:YAG laser source with near-infrared emission at a wavelength of 1064 nm. The treatment protocol consists of 10 sessions delivered on alternate days. Each session will last 60 minutes and will include 15 minutes of laser therapy followed by 45 minutes of conventional physiotherapy. Laser therapy will be applied to two areas of 10 × 10 cm each, located at the anterolateral and posterior aspects of the shoulder. The treatment will be delivered using a pulsed emission with a frequency of 15 Hz, a total energy of 1000 J, and an energy density of 5 J/cm². The mean power will range between 6 and 10.5 W, with a peak power between 1 and 3 kW, for a total application time of 8 minutes and 30 seconds. |
| Sham laser therapy group | Sham comparator | Other: Sham laser therapyThe sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group. The same anatomical areas (two treatment areas of 10 × 10 cm located at the anterolateral and posterior aspects of the shoulder) will be targeted, with identical session duration and patient positioning. During sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Arthroscopic rotator cuff repair of one shoulder for partial or full-thickness tear
- Willingness to provide written informed consent
- Age between 30 and 70 years
- Pain intensity greater than 40/100 on the Visual Analog Scale
Key exclusion criteria (21 listed)
- Psychiatric disorders
- Cognitive impairment
- Rheumatic diseases or Fibromyalgia
- Vascular diseases
- Neoplastic diseases
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 intensity laser therapyHigh-intensity laser therapy (HILT) will be administered using the HIRO TT device (ASA s.r.l., Italy), based on a solid-state Nd:YAG laser source with near-infrared emission at a wavelength of 1064 nm. The treatment protocol consists of 10 sessions delivered on alternate days. Each session will last 60 minutes and will include 15 minutes of laser therapy followed by 45 minutes of conventional physiotherapy. Laser therapy will be applied to two areas of 10 × 10 cm each, located at the anterolateral and posterior aspects of the shoulder. The treatment will be delivered using a pulsed emission with a frequency of 15 Hz, a total energy of 1000 J, and an energy density of 5 J/cm². The mean power will range between 6 and 10.5 W, with a peak power between 1 and 3 kW, for a total application time of 8 minutes and 30 seconds. | Device | High level laser therapy group |
| Sham laser therapyThe sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group. The same anatomical areas (two treatment areas of 10 × 10 cm located at the anterolateral and posterior aspects of the shoulder) will be targeted, with identical session duration and patient positioning. During sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect. | Other | Sham laser therapy group |
Primary outcome
Visual Analogue Scale
Time frame: after 3 weeks
The VAS consists of a 100-mm horizontal line anchored by two descriptors: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants will be asked to mark a point on the line corresponding to their perceived level of pain. The score will be determined by measuring the distance in millimeters from the left end of the line to the patient's mark, with higher scores indicating greater pain intensity.
7 secondary outcomes
Visual Analogue Scale
Time frame: Baseline, after 1 week, after 2 weeks, after 4 months follow-up
Passive Range of Motion
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Active Range of Motion
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Muscle strength: Handheld dynamometer
Time frame: after 3 weeks and after 4 months follow-up
Function: Constant-Murley Score
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Disability: Shoulder Pain Disability Index
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Disability: Quick Disability of the Arm, Shoulder and Hand
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
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 5 May 2026.
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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 intensity laser therapy in people with Rotator Cuff Tears, run by Istituto Ortopedico Rizzoli 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 4 inclusion and 21 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: opening soon, as of the sponsor's last update on 5 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. Some participants in this study may receive a placebo. 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 Lisa Berti, MD (0516366197, lisa.berti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: after 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.