Идёт набор NCT06854016

Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain

Без фазы С лечением Ankle Sprain 1St Degree Ankle Sprain 2Nd Degree Acute Pain

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: Sham Laser therapy, Laser therapy, RICE and physiotherapy/exercise protocol.
Кому может быть актуально: Состояния в реестре: Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Acute Pain. Базовые параметры: от 18 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, Великобритания
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

Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Lateral Ankle Sprain Pain Reduction

Обзор

DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy/exercise program, compared to sham laser combined with standard of care (RICE and physiotherapy/exercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.

Подробное описание

This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

Вмешательства

Устройство Sham Laser therapy
sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
Устройство Laser therapy
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
Другое RICE and physiotherapy/exercise protocol
RICE plus physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes: for the first 2 weeks RICE protocol performed daily at home by the patient, for the following 4 weeks a physiotherapy/exercise protocol will be performed at site with 2 sessions per week.

Первичные конечные точки

Pain change [Срок оценки: 2 weeks after treatment start]

Вторичные конечные точки (1)

Safety - adverse event rate [Срок оценки: through study completion, an average of 12 weeks]

Критерии участия

Критерии включения

Patient male or female with age ≥18 years old
Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.
Patient suffering from LAS pain for no more than 72 hours prior to enrollment
Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
Patient able to provide written informed consent

Критерии исключения

Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to its intended use and indications
Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
Patients who have been administered with corticosteroids after injury
Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)
Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)
Patients with bilateral ankle sprain
Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)
Patients with fractures (as confirmed by radiological examination)
Patients with a diagnosis of active cancer
Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
Patients who are mentally or physically incapacitated
Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator

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

Здоровые добровольцы: Нет