Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

28. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

46

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
      • Bologna, Italien, 40136
        • Istituto Ortopedico Rizzoli

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Sham-komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analogue Scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analogue Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istituto Ortopedico Rizzoli

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. september 2029

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LASER_SHOULDER

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rotator Cuff River

Kliniske forsøg med High intensity laser therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cyprus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner