NCT07349914

Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices

An Investigation of Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices: A Prospective Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Implantable Cardiac Electronic Devices
• Pain
• Upper Extremity
• Posture
• Function
• Daily Activities

Interventions

Type	Name	Description
OTHER	Not applicable- observational study	Not applicable- observational study

Timeline

• Start date: 2025-02-14
• Primary completion: 2027-07-14
• Completion: 2027-08-14
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Turkey (Türkiye)