Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices

Hacettepe University

Status: Invitation-only

Conditions: Daily Activities; Implantable Cardiac Electronic Devices; Posture; Upper Extremity; Function; Pain

Treatments: Other: Not applicable- observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07349914

FTREK25/129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

90 participants in 1 patient group

Individuals with implantable cardiac electronic devices

Description:

Those who have recently undergone implantable cardiac electronic devices implantation Those scheduled for implantable cardiac electronic devices implantation Individuals with implantable cardiac electronic devices

Treatment:

Other: Not applicable- observational study