Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices

Condition(s) studied

Investigational drug(s) / intervention(s)

Not applicable- observational study: Not applicable- observational study

Study 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.

Eligibility

Primary outcome measure(s)

• Shoulder Pain and Disability — Follow-up over 2 years, with assessments every 6 months
  The Shoulder Pain and Disability Index (SPADI) will be used for assessment. The pain subscale comprises 5 items, and participants are asked to rate their pain over the past week during various movements using a Visual Analog Scale between 0 to 10 points. The disability subscale includes 8 items, assessing the level of difficulty experienced during different activities over the past week, also rated on a VAS from 0 (no difficulty) to 10 (unable to perform). Higher scores indicate greater pain and functional limitation. When the entire questionnaire is evaluated, a total score of 0 represents maximum well-being, whereas 130 represents the worst possible condition.
• Assessment of Shoulder Range of Motion — Follow-up over 2 years, with assessments every 6 months
  A universal goniometer will be used to assess the range of motion of the shoulder. Active shoulder flexion, abduction, internal rotation, and external rotation will be measured in accordance with standard assessment principles. Each movement will be measured three times, and the average value will be recorded in degrees.
• Assessment of Upper Extremity Functional Exercise Capacity — Follow-up over 2 years, with assessments every 6 months
  Unsupported Upper Limb Exercise Test (UULEX):Participants will be seated on a chair with their knees touching the wall where the UULEX lines are displayed. The UULEX consists of 8 horizontal levels, each 84 cm in width and 8 cm in height, with 15 cm between the centers of each level. The lowest line corresponds to the participant's knee level. Participants hold a plastic bar weighing 0.2 kg at shoulder width and move it from the hips toward the different levels of the UULEX lines. Each movement starts and ends at the hip joint. The first level is performed for 2 min, and each subsequent level is performed for 1 min. Using a metronome, participants lift the bar 30 times per min. Once participants reach their max height, the 0.2 kg bar is replaced with a 0.5 kg bar, and participants continue lifting to max height. Subsequently, the weight is increased by 0.5 kg per min at the specified level, up to max of 2 kg. Participants are instructed to continue the test until symptom limitation.
• Tightness of muscle — Follow-up over 2 years, with assessments every 6 months
  Pectoralis minor and pectoralis major muscle tightness tests will be performed during musculoskeletal examination using a tape.

Trial sites (1)

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