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Набор по приглашению NCT07349914

Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices

— Наблюдательное Implantable Cardiac Electronic Devices Pain Upper Extremity Posture

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: Not applicable- observational study.
Кому может быть актуально
Состояния в реестре: Implantable Cardiac Electronic Devices, Pain, Upper Extremity, Posture. 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 Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices: A Prospective Study

Обзор

The primary aim of our study is to evaluate shoulder pain, range of motion, postural changes, muscle tightness, activities of daily living, upper extremity functional status, and exercise capacity in individuals with Implantable Cardiac Electronic Devices (ICED), during each follow-up visit over a two-year period, and to compare the assessment outcomes according to different types of implantable cardiac electronic devices. The secondary aim of our study is to investigate the factors determining the severity and duration of shoulder pain in these patients.

Подробное описание

Implantable cardiac electronic devices have revolutionized the treatment of cardiac arrhythmias and significantly reduced the incidence of sudden cardiac death. The number of individuals living with these devices has increased substantially worldwide. Among implantable cardiac electronic devices are pacemakers, cardiac resynchronization therapy pacemakers or biventricular pacemakers, cardiac resynchronization therapy defibrillators, and implantable cardioverter defibrillators . Although cardiac device implantation is considered a minor surgical procedure, several complications may occur, including pocket hematoma, pneumothorax, wound infection, lead dislodgement, fracture, or perforation. In addition to these complications, it is well known that implantation may result in impaired ipsilateral upper extremity function, pain, and restricted shoulder range of motion.

Вмешательства

  • Другое Not applicable- observational study
    Not applicable- observational study

Первичные конечные точки

  • Shoulder Pain and Disability [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Assessment of Shoulder Range of Motion [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Assessment of Upper Extremity Functional Exercise Capacity [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Tightness of muscle [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
Вторичные конечные точки (5)
  • Posture [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Assessment of Musculoskeletal Pain [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Assessment of Upper Extremity Functional Status [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Assessment of Activities of Daily Living [Срок оценки: Follow-up over 2 years, with assessments every 6 months]
  • Assessment of Body Awareness [Срок оценки: Follow-up over 2 years, with assessments every 6 months]

Критерии участия

Критерии включения

  • Aged 18 years or older,
  • Having an implantable cardiac electronic device
  • Meeting the clinical indication for CIED implantation
  • Without any complications at the most recent follow-up,
  • Clinically stable for at least the past month, with any comorbid chronic conditions (e.g., hypertension, diabetes) well-controlled, considered suitable for assessment, and willing to provide informed consent to participate in the study.

Критерии исключения

  • Individuals with neurological, orthopedic, or psychiatric disorders,
  • Individuals with a history of shoulder surgery or shoulder injury,
  • Individuals with cognitive or mental impairments preventing comprehension of the study procedures, or those unwilling to participate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

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

Идентификаторы

NCT: NCT07349914 · FTREK25/129

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗