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An Investigation of Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices: A Prospective Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hacettepe University
Ankara, Samanpazari, Turkey (Türkiye)
Start Date
February 14, 2025
Primary Completion Date
July 14, 2027
Completion Date
August 14, 2027
Last Updated
January 20, 2026
90
ESTIMATED participants
Not applicable- observational study
OTHER
Lead Sponsor
Hacettepe University
NCT06346132
NCT07351968
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