Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures

Официальное название

Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures: A Double-Blind, Randomized, Controlled Clinical Trial

Обзор

This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups. The Control Group will undergo the standard surgical procedure, perform the prescribed home exercises recommended by the hospital service, and use an inactive LED plate (photobiomodulation device). The PBM Group will follow the same surgical and exercise protocols but will use an active PBM device. Home exercises will begin 24 hours after surgery and should be performed twice daily for a total of 12 weeks. The device will be applied once daily to the wrist for 12 minutes (6 minutes on the dorsal side and 6 minutes on the palmar side). The primary outcome will be functional wrist assessment using the QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) questionnaire at 2 weeks. Secondary outcomes will include wrist range of motion, grip strength, wrist function, and pain (assessed using the PRWE-BR instrument), as well as fracture healing. Assessments will be performed at 2, 4, 6, and 12 weeks post-surgery, except for bone consolidation (assessed starting at week 4) and for pain and range of motion, which will also be evaluated at 24 hours.

Подробное описание

Distal radius fracture (DRF) is one of the most common fractures in adults. Its treatment can be either conservative or surgical; however, regardless of the treatment method, it is often associated with pain, loss of function and grip strength, joint stiffness, prolonged absence from work, and even loss of fracture reduction. This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups (1:1 ratio). The Control Group will undergo the standard surgical procedure, perform the prescribed home exercises recommended by the hospital service, and use an inactive LED plate (photobiomodulation device). The PBM Group will follow the same surgical and exercise protocols but will use an active PBM device. Home exercises will begin 24 hours after surgery and should be performed twice daily for a total of 12 weeks. The LED plate will contain 100 light-emitting diodes, distributed as follows: 18 LEDs at 630 nm (23 mW; 117 J/cm²; 8 J per LED); 18 LEDs at 680 nm (20 mW; 102 J/cm²; 7 J per LED); 32 LEDs at 760 nm (24 mW; 122 J/cm²; 9 J per LED); and 32 LEDs at 830 nm (28 mW; 143 J/cm²; 10 J per LED). The device will be applied once daily to the wrist for 12 minutes (6 minutes on the dorsal side and 6 minutes on the palmar side). The primary outcome will be functional wrist assessment using the QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) questionnaire at two weeks. Secondary outcomes will include wrist range of motion, grip strength, wrist function, and pain (assessed using the PRWE-BR instrument), as well as fracture healing. Participants will be blinded to their group allocation and will be evaluated by four researchers who are also blinded to the allocation. Assessments will be performed at 2, 4, 6, and 12 weeks post-surgery, except for bone consolidation (assessed starting at week 4) and for pain and range of motion, which will also be evaluated at 24 hours. In addition to these scheduled assessments, each participant will be followed up with daily phone contact. All collected data will be stored and organized in a secure repository, and appropriate statistical tests will be applied for each specific analysis. A significance level of 5% will be adopted for all tests.

Вмешательства

• Процедура Open reduction and internal fixation (ORIF) with locked volar plate
  All participants will undergo open reduction and internal fixation (ORIF) with a locked volar plate, without postoperative immobilization.
• Процедура Home exercises
  Unsupervised protocol twice daily for 12 weeks, starting 24 hours post-surgery
• Устройство Active photobiomodulation
  The intervention consists of an active photobiomodulation wrist brace equipped with 100 light-emitting diodes (LEDs), including 18 LEDs at 630 nm delivering 23 mW of power, 117 J/cm², and 8 J per LED; 18 LEDs at 680 nm delivering 20 mW of power, 102 J/cm², and 7 J per LED; 32 LEDs at 760 nm delivering 24 mW of power, 122 J/cm², and 9 J per LED; and 32 LEDs at 830 nm delivering 28 mW of power, 143 J/cm², and 10 J per LED. The device will be applied once daily for a total of 12 minutes, with six m
• Устройство Inactive photobiomodulation
  The intervention consists of an inactive LED wrist plate that is identical in appearance and sound to the active device but contains no active LEDs. It will be applied once daily for 12 minutes, during which the device will emit only activation light and sound, without delivering therapeutic irradiation.

Первичные конечные точки

• Quick-DASH functional scale - 2 weeks [Срок оценки: up to 2 weeks]

Вторичные конечные точки (12)

• Quick-DASH functional scale - 4 weeks [Срок оценки: up to 4 weeks]
• Quick-DASH functional scale - 6 weeks [Срок оценки: up to 6 weeks]
• Quick-DASH functional scale - 12 weeks [Срок оценки: up to 12 weeks]
• Pain - 24 hours [Срок оценки: up to 24 hours]
• Pain - 2 weeks [Срок оценки: up to 2 weeks]
• Pain - 4 weeks [Срок оценки: up to 4 weeks]
• Pain - 6 weeks [Срок оценки: up to 6 weeks]
• Pain - 12 weeks [Срок оценки: up to 12 weeks]
• Analgesic consumption - 2 weeks [Срок оценки: up to 2 weeks]
• Analgesic consumption - 4 weeks [Срок оценки: up to 4 weeks]
• Analgesic consumption - 6 weeks [Срок оценки: up to 6 weeks]
• Analgesic consumption - 12 weeks [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• Adults aged 18 to 65 years,
• Both sexes,
• Patients with isolated, closed distal radius fractures with displacement and surgical indication,
• Surgical indication defined by instability criteria:
• Dorsal tilt of the distal fragment >20°,
• Radial shortening ≥10 mm,
• Articular incongruity,
• Dorsal comminution,
• Fractures classified as Fernandez types I, II, or III,
• Fractures classified as AO/OTA types 2R3A2, 2R3A3, 2R3B, or 2R3C (except 2R3C3).

Критерии исключения

• Previous wrist injuries, sequelae, or motor deficits due to neurological lesions,
• Pathological fractures,
• Ipsilateral fractures in other regions of the limb,
• Neurovascular injury with sensory deficit at the fracture site,
• Local or systemic contraindications to surgery or postoperative recovery,
• History of photosensitivity,
• Neurological and/or psychiatric disorders,
• Proliferative or infectious skin lesions at the wrist region,
• Pregnancy,
• Surgical complications (neurological or vascular injuries, or fracture line extension) - excluded from analysis but reported.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• ACN Municipal Hospital — São Paulo

Идентификаторы

NCT: NCT07426926 · 6.809.544

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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