The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation After Total Knee Arthroplasty

Официальное название

The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation: 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 total knee arthroplasty (TKA). Persistent pain and functional limitations are common after TKA despite standard rehabilitation, highlighting the need for adjunctive therapies to optimize postoperative recovery. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects; however, its effectiveness in this population 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 lasting 60 minutes, including 15 minutes of active or sham laser therapy and 45 minutes of conventional physiotherapy. The primary outcome is postoperative pain. Secondary outcomes include joint swelling, range of motion, muscle strength, physical function, and quality of life. Assessments will be conducted at baseline (preoperative), at 1 month after surgery (prior to the start of rehabilitation), during the rehabilitation program (after the fourth, seventh, and tenth physiotherapy sessions), and at 4 months postoperatively (follow-up). A total of 46 participants (23 per group) will be enrolled in the study.

Вмешательства

• Устройство High level laser therapy
  High-intensity laser therapy (HILT) will be delivered using the HIRO TT device (ASA S.r.l.), which employs a patented pulsed laser system (FDA-approved in 2003) based on a solid-state Nd:YAG source emitting near-infrared (NIR) radiation at a wavelength of 1064 nm. The device operates with a mean power of 10.5 W and a peak power of 3 kW. Three treatment areas (each measuring 15 × 10 cm) will be targeted: two longitudinal areas over the quadriceps muscle and one transverse area over the knee join
• 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 longitudinal areas over the quadriceps muscle and one transverse area over the knee joint) will be targeted, with identical session duration and 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 blindin

Первичные конечные точки

• Visual Analogue Scale [Срок оценки: after 3 weeks]

Вторичные конечные точки (5)

• Visual Analogue Scale [Срок оценки: Baseline, after 1 week, after 2 weeks, after 4 months follow-up]
• Range of Motion [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
• Swelling [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
• Lower limb muscle strength [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]
• Western Ontario and McMaster Universities Osteoarthritis Index [Срок оценки: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up]

Критерии участия

Критерии включения

• Patients undergoing primary unilateral total knee arthroplasty for primary knee osteoarthritis
• Age between 50 and 80 years
• Pain intensity greater than 30/100 on the Visual Analog Scale (VAS)
• Ability and willingness to provide written informed consent

Критерии исключения

• Psychiatric disorders
• Cognitive impairments
• Previous major trauma or surgery involving the affected knee
• Rheumatic diseases or fibromyalgia
• Vascular diseases
• Neoplastic diseases
• Infectious diseases
• Neurological disorders
• Hemophilia or bleeding disorders
• Current anticoagulant therapy
• Presence of a pacemaker
• History of epileptic seizures
• Known hypersensitivity or contraindication to laser therapy
• Suspected conditions in which tissue heating is contraindicated
• Use of photosensitizing medications or known photosensitivity
• Skin lesions or abrasions at the treatment site
• Tattoos in the treatment area
• Intra-articular steroid injections in the target knee within the previous 2-3 weeks
• Recent significant trauma or injury
• Use of anti-inflammatory or analgesic medications or other pain-relieving treatments (if not controlled or standardized)
• Pregnancy or breastfeeding
• Positive status for human immunodeficiency virus

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Идентификаторы

NCT: NCT07568262 · LASER_KNEE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗