Subacromial Impingement SyndromeNCT03658707
Validity and Reliability of the Turkish Version of the Functional Shoulder Score
An observational study of Subacromial Impingement Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- questionnaire
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2018to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with subacromial impingement syndrome from the outpatient clinic of the Dokuz Eylul University, Faculty of Medicine, Department of Orthopedics and Traumatology.
Who may be able to join
- Diagnosis of subacromial impingement syndrome (Michener et al, 2009)
- To read and understand Turkish
Who cannot join
- 50% limitation of passive shoulder range of motion in ≥ 2 planes of motion
- Glenohumeral instability
- Fracture or surgery history in the shoulder
- Another diagnosis that may affect shoulder function (frozen shoulder, primary shoulder arthritis, inflammatory/ neoplastic/neurological conditions, cervical spine induced pain)
- Systemic musculoskeletal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Izmir
Damla KARABAY, MS
About this study
Official title: Validity and Reliability of the Turkish Version of the Functional Shoulder Score in Patients With Subacromial Impingement Syndrome
The aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS).
Read the detailed description
The original form of the Functional Shoulder Score will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. The pre-final version will be composed and tested on a group of patients with SIS. If necessary, readjustments will be made, and the validity of the final version will be investigated in 116 patients with SIS. Additionally, for the test-retest reliability, 59 patients will fill out the questionnaire again after 3-7 days.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- questionnaire
- Keywords
- Functional shoulder score, questionnaire, subacromial impingement syndrome
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Shoulder questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Shoulder Score
The questionnaire includes 11 items: One is about shoulder pain intensity and 10 is about the shoulder function. The minimum score is 0 (worst) and the maximum score is 100 (best).
Measured: Baseline - within 3-7 days after the baseline
Secondary outcomes (5)
Modified Constant Murley Shoulder Score
100 points total score of this score consists of 15 points of pain, 20 points of daily activities, 40 points of the active range of motion, and 25 points of strength. The minimum score is 0 (worst) and the maximum score is 100 (best).
Measured: Baseline
American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form
The patient self-evaluation questionnaire includes 11 item; one is about shoulder pain intensity and 10 are about the shoulder function.The minimum score is 0 (worst) and the maximum score is 100 (best).
Measured: Baseline
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
The disability level of the upper extremity is determined by 30 questions; 21 questions are about physical function, 3 questions are about social/role function and 6 questions are about the symptoms of the patient. The minimum score is 0 (best) and the maximum score is 100 (worst).
Measured: Baseline
Western Ontario Rotator Cuff (WORC) index
The disease-specific questionnaire includes 21 items, 4 about physical symptoms, 4 about sport/recreation, 4 about work, 4 about lifestyle and 4 about emotions. The minimum score is 0 (worst) and the maximum score is 100 (best).
Measured: Baseline
Global rating scale
The global shoulder function is graded between 0 (no use) and 10 (normal function) on a scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start23 Nov 2018
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Karabay, Izmir Katip Celebi University
- Investigators
- Sevgi Sevi YESILYAPRAK, PhD, Study director, Dokuz Eylul UniversityHalime Ezgi TURKSAN, Study chair, Dokuz Eylul UniversityMehmet ERDURAN, MD, Study chair, Dokuz Eylul UniversityDamla KARABAY, MSc, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658707
- Sponsor's protocol ID
- 3864-GOA
- Status last verified
- Jul 2022
- First submitted
- 2 Sep 2018
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Functional Shoulder Score in Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT03658707
- Acronym / sponsor ID
- 3864-GOA
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Functional shoulder score, questionnaire, subacromial impingement syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 5 Sep 2018 (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 aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS).
Detailed description
The original form of the Functional Shoulder Score will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. The pre-final version will be composed and tested on a group of patients with SIS. If necessary, readjustments will be made, and the validity of the final version will be investigated in 116 patients with SIS. Additionally, for the test-retest reliability, 59 patients will fill out the questionnaire again after 3-7 days.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacromial impingement syndrome from the outpatient clinic of the Dokuz Eylul University, Faculty of Medicine, Department of Orthopedics and Traumatology.
Key inclusion criteria (2 listed)
- Diagnosis of subacromial impingement syndrome (Michener et al, 2009)
- To read and understand Turkish
Key exclusion criteria (5 listed)
- 50% limitation of passive shoulder range of motion in ≥ 2 planes of motion
- Glenohumeral instability
- Fracture or surgery history in the shoulder
- Another diagnosis that may affect shoulder function (frozen shoulder, primary shoulder arthritis, inflammatory/ neoplastic/neurological conditions, cervical spine induced pain)
- Systemic musculoskeletal disease
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 |
|---|---|---|
| questionnaireShoulder questionnaire | Other | – |
Primary outcome
Functional Shoulder Score
Time frame: Baseline - within 3-7 days after the baseline
The questionnaire includes 11 items: One is about shoulder pain intensity and 10 is about the shoulder function. The minimum score is 0 (worst) and the maximum score is 100 (best).
5 secondary outcomes
Modified Constant Murley Shoulder Score
Time frame: Baseline
American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form
Time frame: Baseline
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Time frame: Baseline
Western Ontario Rotator Cuff (WORC) index
Time frame: Baseline
Global rating scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sevgi Sevi YESILYAPRAK, PhD study director
Dokuz Eylul University
Halime Ezgi TURKSAN study chair
Dokuz Eylul University
Mehmet ERDURAN, MD study chair
Dokuz Eylul University
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 Subacromial Impingement Syndrome, run by Dokuz Eylul 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damla KARABAY (2323293535 ext. +90, damla.gulpinar@ikc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Shoulder Score (time frame: Baseline - within 3-7 days after the baseline). 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 27 Jul 2022.