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Идёт набор NCT07496203

The Effectiveness of BETY in Knee Osteoarthritis With Intra-Articular Injections

Без фазы С лечением Osteo Arthritis of the Knee Pain Pain Management Exercise

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: BETY.
Кому может быть актуально
Состояния в реестре: Osteo Arthritis of the Knee, Pain, Pain Management, Exercise. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

An Investigation of the Effectiveness of the BETY Exercise Program, Based on the Biopsychosocial Model, in Individuals With Knee Osteoarthritis Who Have Received Intra-articular Injections

Обзор

Osteoarthritis (OA) is the most common condition in middle-aged and elderly populations; it causes pain and physical disability and is characterized by cartilage degeneration, changes in bone tissue, inflammation of the synovial membrane, and an increased inflammatory response. Because pain and depression often co-occur in individuals diagnosed with OA, the concepts of disability and health-related quality of life caused by the disease have become more decisive than radiological joint damage. The chronic nature of the disease, like other chronic conditions, encompasses a range of biopsychosocial impacts, including pain, fatigue, sleep disturbances, functional loss, anxiety, depression, and social isolation. This complex structure is accompanied by a pattern in which inflammatory processes are triggered. Recently, intra-articular injections (such as Platelet-Rich Plasma Therapy (PRP), Hyaluronic Acid (HA), PRP+HA combinations, Corticosteroids, Prolotherapy, and Stem Cells) have been accepted as a treatment for OA. Regarding the mechanism of these intra-articular injections, it has been reported that a combination of various anabolic and anti-inflammatory cytokines may treat inflammation associated with the early stages of OA. It has been demonstrated that, through the effects of various growth factors, these treatments have a positive impact on chondrogenesis and mesenchymal stem cell proliferation by increasing anti-inflammatory mediators and reducing pro-inflammatory mediators. Bilişsel Egzersiz Terapi Yaklaşımı - BETY (Cognitive Exercise Therapy Approach in english) is an exercise approach based on the biopsychosocial model. BETY consists of innovations in function-oriented body stabilization exercises (FoGSE), chronic pain management (BETY-Nociplastic Pain Management (BETY-NPM)), emotion-mood information management (dance therapy-authentic movement), and sexuality information management. The aim of this study is to investigate the effectiveness of BETY, which is often initiated following intra-articular injections-a treatment frequently chosen for individuals diagnosed with knee osteoarthritis (OA).

Вмешательства

  • Другое BETY
    Participants in this group will follow a traditional exercise program consisting of active range-of-motion exercises for the knee joint, isometric muscle strengthening, and stretching exercises targeting the lower extremity muscle groups.

Первичные конечные точки

  • BETY-BQ [Срок оценки: 6 months]
  • Muscle Strength [Срок оценки: 6 months]
Вторичные конечные точки (12)
  • Health Asessement Questionnaire (HAQ) [Срок оценки: 6 mounths]
  • Hospital Anxiety Depression Scale (HADS) [Срок оценки: 6 mounths]
  • Short Form - 36 [Срок оценки: 6 months]
  • WOMAC Osteoarthritis Index [Срок оценки: 6 mounths]
  • Pain Catastrophizing Scale [Срок оценки: 6 mounths]
  • Tampa Scale of Kinesiophobia [Срок оценки: 6 months]
  • Time Up and Go Test [Срок оценки: 6 mounths]
  • Stair Climb Test [Срок оценки: 6 mounths]
  • 30s Sit to Stand test [Срок оценки: 6 mounths]
  • 10 m Walk Tets [Срок оценки: 3 mounths]
  • 6 min Walk Test [Срок оценки: 6 mounths]
  • Muscle Endurance [Срок оценки: 6 mounths]

Критерии участия

Критерии включения

  • Diagnosis of knee osteoarthritis according to ACR knee osteoarthritis diagnostic criteria
  • Being in stage 2 or 3 according to Kellgren-Lawrence radiological staging criteria
  • having received an intra-articular injection in the knee within the past month
  • To be 18 years of age or older
  • Being a reader-writer
  • Having read and signed the informed consent

Критерии исключения

  • History of major psychiatric illness
  • Having malignant disease
  • Having chronic infectious or other rheumatologic diseases
  • Serious knee trauma or surgical operation in the last 6 months
  • Having collagen tissue disease
  • History of peripheral vascular disease or neuropathy
  • Being in stage 4 according to Kellgren Lawrence radiologic staging criteria
  • To have received a physiotherapy program for the relevant knee in the last 3 months

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
Простое слепое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe University — Ankara

Идентификаторы

NCT: NCT07496203 · FTREK25_143

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗