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Набор скоро начнётся NCT06630208

Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome

Без фазы С лечением Chronic Postsurgical 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: Myofascial release, Breathing exercises, Pharmacological treatment.
Кому может быть актуально
Состояния в реестре: Chronic Postsurgical Pain. Базовые параметры: 55 лет — 65 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
Египет
Следующий шаг
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Обзор

The main aim of this study is to investigate the effectiveness of Myofascial release in patients with chronic sternotomy pain.

Подробное описание

Post-sternotomy pain syndrome (PSPS) is a prevalent disorder affecting a substantial proportion of patients who have undergone sternotomy surgery, with incidence rates ranging from 10% to 40%. Several mechanisms have been proposed to be responsible for the development of PSPS; for example, intercostal neuralgia from scar-entrapped neuroma, brachial plexus injury, ribs or costal fractures with incomplete healing, sternal wound infections and even hypersensitivity reaction to sternal wire. chronic post sternotomy pain (CPSP) can compromise quality of life, affecting their sleep patterns and impairing their working ability.

During the first week after coronary artery bypass grafting (CABG) surgery, vital capacity (VC) decreases by 30-60% and even up to 1 year this remains reduced by 12%. Reduced VC has a negative effect on exercise tolerance (Vo2max) and therefore it is important to optimize pulmonary function after CABG surgery. The decreased thoracic mobility after CABG still presents 12 months after surgery. Thoracic mobility and vital capacity were affected more when the left internal thoracic artery (LITA)-retractor was used and reduced thoracic mobility is related to diminished pulmonary function.

New therapeutic-rehabilitative proposals have been tried in cardiac patients. After cardiac surgery, it was found that the responses of the cardiovascular, and respiratory systems get better after neuromuscular manual therapy. The strong correlation between manual therapy and its effects, suggests that a central control mechanism could be activated by manual therapy.

Using Myofascial release (MFR) techniques may be beneficial for patients post-CABG and off-pump coronary artery bypass grafting (OPCAB) surgery. The advantages of MFR techniques are gentleness and non-invasiveness. During therapy one works with fascia structures, thus, not influencing bone structures directly, These techniques are comfortable and safe, they may be applied in acute conditions.

Вмешательства

  • Другое Myofascial release
    The experimental group will undergo a 5-day consecutive myofascial release treatment, administered as Osteopathic Manipulative Treatment (OMT), with each session lasting a maximum of 15 minutes. The treatment will consist of three phases targeting the entire mediastinum: Thoracic Inlet (Indirect) Myofascial Release, Rib Raising with continued stretch of the paraspinal muscles to the L2 vertebral level, and Soft Tissue Cervical Paraspinal Muscle Stretch with Suboccipital Muscle Release. Participa
  • Другое Breathing exercises
    Following the 3 phases of myofascial release, breathing exercises will be done for patients.
  • Препарат Pharmacological treatment
    Patients will take pharmacological treatment prescribed by the cardiologist.

Первичные конечные точки

  • Visual analog scale (VAS) [Срок оценки: 5 days]
  • Upper chest expansion [Срок оценки: 5 days]
  • Lower chest expansion [Срок оценки: 5 days]
  • Pressure pain threshold [Срок оценки: 5 days]
Вторичные конечные точки (8)
  • Forced vital capacity (FVC) [Срок оценки: 5 days]
  • Forced expiratory volume at one second (FEV1) [Срок оценки: 5 days]
  • FEV1/FVC [Срок оценки: 5 days]
  • 6-min walk test (6 MWT) [Срок оценки: 5 days]
  • Katz Index of Independence in Activities of Daily Living (ADL) [Срок оценки: 5 days]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 5 days]
  • Arabic version of the 12-item short-form health survey (SF-12) [Срок оценки: 5 days]
  • The Readiness for Return to Work (RRTW) [Срок оценки: 5 days]

Критерии участия

Критерии включения

  • Chronic Post-sternotomy pain (CPSP), defined as discomfort at the thorax after cardiac surgery, persisting for at least 2 months, and without apparent cause (I.e., such as infection or the underlying disease that motivated the surgery).
  • Age between 55 to 65 years old.
  • All patients will be under full medical supervision.
  • Adherence to informed consent.
  • Cardiac sternotomy intervention

Критерии исключения

  • Neuromuscular disorders.
  • Any Active hemorrhage.
  • The presence of an unstable cardiac, pulmonary or cerebral pathology.
  • Poor cognition and mentality.
  • Patients with active contagious skin conditions
  • Any Cardiopulmonary problems (eg. Uncontrolled hypertension, Heart Failure, Arrhythmia)
  • Patients with malignancy.
  • Any acute viral infection.
  • Patients with ascites or end-stage liver or kidney failure.
  • Patients will participate in other physiotherapy programs rather than the prescribed protocol.
  • Chest infection in last 3 months.
  • Patients with musculoskeletal problems like any bone fracture
  • Osteoporotic patients.
  • Any recent open wound in the chest are.
  • Hemodynamic instability.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cairo University — Giza

Идентификаторы

NCT: NCT06630208 · P.T.REC/012/005235

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗