The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lisa Berti, MD
- Telefonnummer: 0516366197
- E-post: lisa.berti@ior.it
Studieorter
-
-
-
Bologna, Italien, 40136
- Istituto Ortopedico Rizzoli
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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 Comparator: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LASER_SHOULDER
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .