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

28 aprile 2026 aggiornato da: Istituto Ortopedico Rizzoli

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

46

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Italia
      • Bologna, Italia, 40136
        • Istituto Ortopedico Rizzoli

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: High level laser therapy group

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.
Dispositivo: 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 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.
Comparatore fittizio: Sham laser therapy group

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.
Altro: 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 participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analogue Scale
Lasso di tempo: 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.
after 3 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analogue Scale
Lasso di tempo: 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.
Baseline, after 1 week, after 2 weeks, after 4 months follow-up
Passive Range of Motion
Lasso di tempo: 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.
Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Active Range of Motion
Lasso di tempo: 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.
Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Muscle strength: Handheld dynamometer
Lasso di tempo: 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.
after 3 weeks and after 4 months follow-up
Function: Constant-Murley Score
Lasso di tempo: 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.
Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Disability: Shoulder Pain Disability Index
Lasso di tempo: 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.
Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Disability: Quick Disability of the Arm, Shoulder and Hand
Lasso di tempo: 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.
Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istituto Ortopedico Rizzoli

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 settembre 2029

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LASER_SHOULDER

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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