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Enrolling by invitation NCT07349914

Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices

— Observational Implantable Cardiac Electronic Devices Pain Upper Extremity Posture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Implantable Cardiac Electronic Devices, Pain, Upper Extremity, Posture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Not applicable- observational study
    Not applicable- observational study

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

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

Identifiers

NCT: NCT07349914 · FTREK25/129

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗