Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices (NCT07349914) | Clinical Trial Compass
By InvitationNot Applicable
Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices
Turkey (Türkiye)90 participantsStarted 2025-02-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Shoulder Pain and Disability
Timeframe: Follow-up over 2 years, with assessments every 6 months
2
Assessment of Shoulder Range of Motion
Timeframe: Follow-up over 2 years, with assessments every 6 months
3
Assessment of Upper Extremity Functional Exercise Capacity
Timeframe: Follow-up over 2 years, with assessments every 6 months
4
Tightness of muscle
Timeframe: Follow-up over 2 years, with assessments every 6 months