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

N/ANot Yet RecruitingNCT07568288

Istituto Ortopedico Rizzoli46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Interventions

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: after 3 weeks

Secondary Outcomes

Visual Analogue Scale

Time frame: 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.