NCT07568288

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
37mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Rotator Cuff Tears

Keywords

Arthroscopic rotator cuff repairRotator cuff repairlaser therapyHigh intensity laser therapyRehabilitationShoulder pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 3 weeks

Secondary Outcomes (7)

  • Visual Analogue Scale

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

  • Passive Range of Motion

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

  • Active Range of Motion

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

  • Muscle strength: Handheld dynamometer

    after 3 weeks and after 4 months follow-up

  • Function: Constant-Murley Score

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

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Sham laser therapy

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.

High level laser therapy group
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.

Sham laser therapy group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa Berti, MD

CONTACT

0516366197lisa.berti@ior.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

IT(1)