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

Official title

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

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.

Interventions

• Device High intensity laser therapy
  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 anterolat
• Other Sham laser therapy
  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 part

Primary outcome measures

• Visual Analogue Scale [Time frame: after 3 weeks]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Istituto Ortopedico Rizzoli — Bologna

Identifiers

NCT: NCT07568288 · LASER_SHOULDER

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗