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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorIstituto Ortopedico Rizzoli

About this 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.

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Psychiatric disorders

Cognitive impairment

Rheumatic diseases or Fibromyalgia

Vascular diseases

Trial design

Treatments tested in this trial

  • High intensity laser therapy
  • Sham laser therapy

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators