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NCT Number: NCT07568288

The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair.

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.

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Key information

Conditions

Rotator Cuff Tears Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Psychiatric disorders
  • Cognitive impairment
  • Rheumatic diseases or Fibromyalgia
  • Vascular diseases
  • Neoplastic diseases
  • Infectious diseases
  • 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

Treatment and study plan

High intensity laser therapy

Device

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 therapy

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: Baseline, after 1 week, after 2 weeks, after 4 months follow-up

    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.

  2. Passive Range of Motion

    Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

    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.

  3. Active Range of Motion

    Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

    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.

  4. Muscle strength: Handheld dynamometer

    Time frame: after 3 weeks and after 4 months follow-up

    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.

  5. Function: Constant-Murley Score

    Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

    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.

  6. Disability: Shoulder Pain Disability Index

    Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

    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.

  7. 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

    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.

Study contacts

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

Lisa Berti, MD

CONTACT

[email protected]

0516366197

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 5, 2026
Registry last updated
May 5, 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.

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