Implantable Cardiac Electronic DevicesNCT07349914
Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices
An observational study of Implantable Cardiac Electronic Devices and Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardiac Electronic Devices, Pain, Upper Extremity
- What is being tested?
- Not applicable- observational study
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2025to 14 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adults aged 18 years and older who have an implantable cardiac electronic device, including pacemakers, cardiac resynchronization therapy devices (CRT-P or CRT-D), or implantable cardioverter defibrillators (ICD).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
Official title: An Investigation of Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices: A Prospective Study
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.
Read the 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
- Being tested
- Not applicable- observational study
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Individuals with implantable cardiac electronic devices | Those who have recently undergone implantable cardiac electronic devices implantation Those scheduled for implantable cardiac electronic devices implantation Individuals with implantable cardiac electronic devices Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability
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.
Measured: Follow-up over 2 years, with assessments every 6 months
Assessment of Shoulder Range of Motion
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.
Measured: Follow-up over 2 years, with assessments every 6 months
Assessment of Upper Extremity Functional Exercise Capacity
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.
Measured: Follow-up over 2 years, with assessments every 6 months
Tightness of muscle
Pectoralis minor and pectoralis major muscle tightness tests will be performed during musculoskeletal examination using a tape.
Measured: Follow-up over 2 years, with assessments every 6 months
Secondary outcomes (5)
Posture
Posture will be examined via the Corbin Postural Assessment Scale. The total points of the Corbin Postural Assessment Scale range from 0 to 28 points. A higher point represents worse posture.
Measured: Follow-up over 2 years, with assessments every 6 months
Assessment of Musculoskeletal Pain
Musculoskeletal pain will be assessed using the Nordic Musculoskeletal Questionnaire (NMQ). This questionnaire evaluates symptoms (pain, discomfort, numbness) over the past 12 months in nine anatomical regions: neck, shoulders, elbows, wrists/hands, upper back, lower back, hips/thighs, knees, and ankles/feet. Participants are asked whether these symptoms have interfered with their work (at home or outside) during the past 12 months and whether they have experienced pain in any of these nine regions at any time during the past seven days.
Measured: Follow-up over 2 years, with assessments every 6 months
Assessment of Upper Extremity Functional Status
Upper extremity functional status will be evaluated using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. The QuickDASH is a shortened version of the full Disabilities of the Arm, Shoulder, and Hand questionnaire, consisting of 11 items. The scoring system is the same as the long version, using a 5-point Likert scale. According to this scale, upper extremity activity is rated as follows: 1 - no difficulty, 2 - mild difficulty, 3 - moderate difficulty, 4 - severe difficulty, and 5 - unable to perform. The total score ranges from 0 to 100, where 0 indicates no functional impairment and 100 indicates maximum functional limitation.
Measured: Follow-up over 2 years, with assessments every 6 months
Assessment of Activities of Daily Living
The Nottingham Extended Activities of Daily Living Scale (NEADLS) will be used to evaluate participants' daily living activities across four subdomains: mobility, kitchen, domestic, and leisure activities. Responses are scored as follows: 0 = unable to perform, 1 = able to perform with assistance, 2 = able to perform independently but with difficulty, and 3 = able to perform independently and easily. The total score ranges from 0 to 66, with higher scores indicating greater independence in daily living activities.
Measured: Follow-up over 2 years, with assessments every 6 months
Assessment of Body Awareness
Body awareness will be evaluated using the Body Awareness Rating Questionnaire. This questionnaire was developed to assess individuals' difficulties in perceiving and describing their bodily sensations and functions. It evaluates body awareness across four parameters: function, sensations, mood, and awareness. Each item is scored on a 7-point Likert scale. Each parameter receives a score ranging from 6 to 42, with higher scores indicating greater body awareness. Participants will be asked to read each statement within every parameter and select the score that best represents their experience.
Measured: Follow-up over 2 years, with assessments every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start14 Feb 2025
- Primary completion14 Jul 2027 (estimated)
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Cardiac Electronic DevicesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349914
- Sponsor's protocol ID
- FTREK25/129
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices: A Prospective Study
- ClinicalTrials.gov ID
- NCT07349914
- Acronym / sponsor ID
- FTREK25/129
- Conditions
- Implantable Cardiac Electronic Devices, Pain, Upper Extremity, Posture, Function, Daily Activities
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 14 Aug 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with implantable cardiac electronic devices | – | Other: Not applicable- observational studyThose who have recently undergone implantable cardiac electronic devices implantation Those scheduled for implantable cardiac electronic devices implantation Individuals with implantable cardiac electronic devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults aged 18 years and older who have an implantable cardiac electronic device, including pacemakers, cardiac resynchronization therapy devices (CRT-P or CRT-D), or implantable cardioverter defibrillators (ICD).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Individuals with implantable cardiac electronic devices |
Primary outcome
Shoulder Pain and Disability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Cardiac Electronic Devices and Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability (time frame: Follow-up over 2 years, with assessments every 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.