Набор скоро начнётся NCT07568288

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

Без фазы С лечением Rotator Cuff Tears

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: High intensity laser therapy, Sham laser therapy.
Кому может быть актуально: Состояния в реестре: Rotator Cuff Tears. Базовые параметры: 30 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Устройство 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 anterolat
Другое 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 part

Первичные конечные точки

Visual Analogue Scale [Срок оценки: after 3 weeks]

Вторичные конечные точки (7)

Visual Analogue Scale [Срок оценки: Baseline, after 1 week, after 2 weeks, after 4 months follow-up]
Passive Range of Motion [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
Active Range of Motion [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
Muscle strength: Handheld dynamometer [Срок оценки: after 3 weeks and after 4 months follow-up]
Function: Constant-Murley Score [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
Disability: Shoulder Pain Disability Index [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
Disability: Quick Disability of the Arm, Shoulder and Hand [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]

Критерии участия

Критерии включения

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