Shoulder LesionsNCT05391516
Development a New Scale for Assessment Shoulder Problems
An observational study of Shoulder Lesions and Shoulder Injuries, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to develop and psychometrically validate the Shoulder Problems Assessment Scale (SPAS), a culturally grounded patient-reported outcome measure designed to assess shoulder-related functional limitations in Turkish adults using a hierarchical stepwise yes/no response format. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Lesions, Shoulder Injuries, Shoulder Pain
- What is being tested?
- Evaluation of shoulder problems
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 16 Jul 2025
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population consists of adults aged 18-80 years with shoulder-related pain and/or functional limitation who were referred to or receiving care in physical therapy and rehabilitation units across multiple regions of Turkey. Participants represent a heterogeneous clinical spectrum of shoulder conditions, including rotator cuff-related disorders, adhesive capsulitis, traumatic shoulder lesions, and degenerative conditions. Individuals were recruited from multiple clinical centers to ensure diversity in demographic and clinical characteristics. All participants provided written and verbal informed consent prior to participation.
Who may be able to join
- Adults aged 18-80 years Presence of shoulder-related pain and/or functional limitation Referred to or receiving treatment in a physical therapy or rehabilitation unit Ability to understand and respond to the questionnaire items Provision of written and verbal informed consent
Who cannot join
- Neurological disorders affecting upper extremity function Systemic inflammatory or rheumatologic diseases involving the shoulder Severe cognitive impairment or psychiatric conditions that may interfere with questionnaire completion Acute trauma or fracture of the shoulder region requiring emergency management Incomplete or incorrectly completed questionnaire forms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Psychometric Validation of the Shoulder Problems Assessment Scale: A Culturally Grounded Patient-Reported Outcome Measure With a Hierarchical Stepwise Yes/No Response Format
The purpose of this study is to develop and psychometrically validate the Shoulder Problems Assessment Scale (SPAS), a culturally grounded patient-reported outcome measure designed to assess shoulder-related functional limitations in Turkish adults using a hierarchical stepwise yes/no response format. SPAS items are structured as four ordered difficulty thresholds for common daily activities, allowing respondents to indicate the point at which difficulty first begins while keeping the response task cognitively simple.
Scale development followed a four-stage process including literature review, semi-structured patient interviews, expert content validation (Lawshe method), pilot testing, and main field testing in multiple physical therapy units across Turkey. In the main application, SPAS was administered to individuals with shoulder problems and evaluated for construct validity using exploratory and confirmatory factor analyses, reliability using internal consistency and test-retest intraclass correlation coefficients (3-7 days), and concurrent validity through correlation with the Shoulder Pain and Disability Index (SPADI). Receiver operating characteristic (ROC) analysis was performed to derive a clinically interpretable SPAS cut-off value using a SPADI-based functional limitation reference. The study aims to provide a valid, reliable, practical, and culturally appropriate PROM that can be used in routine clinical assessment and research in Turkey.
Read the detailed description
This study was designed to develop and psychometrically validate the Shoulder Problems Assessment Scale (SPAS), a patient-reported outcome measure intended to assess shoulder-related functional limitations in adults. SPAS was developed to address limitations of existing shoulder scales related to cognitive burden, cultural relevance, and response format, particularly in populations with varying health literacy levels.
The development process followed a four-stage methodological framework. In the first stage, the conceptual framework and initial item pool were established through a comprehensive literature review, semi-structured interviews with patients experiencing shoulder problems, and input from experienced physical therapists. These steps aimed to identify daily activities that commonly provoke functional difficulty in routine life. An initial pool of 34 items was generated, including activity-based items structured in a hierarchical stepwise yes/no format.
In the second stage, content validity was evaluated by an expert panel using the Lawshe method. Items with insufficient content validity or conceptual overlap were revised, combined, or removed. A pilot study was then conducted to assess item clarity, cultural appropriateness, and comprehensibility. Based on expert feedback and pilot results, the item pool was refined and prepared for the main application.
The third stage consisted of a multicenter field application conducted in physical therapy units across multiple regions of Turkey. SPAS was administered to individuals with shoulder problems, followed by the Turkish version of the Shoulder Pain and Disability Index (SPADI) for concurrent validity assessment. A subgroup of participants with stable clinical status completed SPAS again after 3-7 days to evaluate test-retest reliability.
In the final stage, psychometric analyses were performed. Construct validity was examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) with a robust diagonally weighted least squares estimator appropriate for the hierarchical response structure. Reliability was assessed using internal consistency coefficients and intraclass correlation coefficients. Concurrent validity was evaluated through correlations with SPADI scores. Receiver operating characteristic (ROC) analysis was conducted to determine a clinically interpretable cut-off value for SPAS using a SPADI-derived functional limitation reference.
SPAS consists of 12 activity-based items, each comprising four ordered difficulty levels. Respondents indicate the level at which difficulty first appears, reflecting a threshold-based approach to functional limitation rather than graded symptom intensity. Total scores range from 0 to 48, with higher scores indicating greater functional limitation. The study aims to provide a valid, reliable, and practical instrument for assessing shoulder-related functional limitations in clinical and research settings.
- Conditions
- Shoulder Lesions, Shoulder Injuries, Shoulder Pain
- Being tested
- Evaluation of shoulder problems
- Keywords
- Shoulder Pain, Shoulder Activity, Shoulder Evaluation
- Medical subject headings
- Shoulder Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of shoulder problemsDiagnostic test
The developed items and Shoulder Pain and Disability Index-SPADI will be directed to the participants.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants; 18-80 years old, who volunteered to participate in the study, patients with shoulder problems. Receives: Diagnostic Test: Evaluation of shoulder problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity of the Shoulder Problems Assessment Scale (SPAS)
Construct validity of the Shoulder Problems Assessment Scale (SPAS) will be evaluated by examining its factor structure using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). A three-factor model representing joint mobility, functionality, and pain will be tested. Model fit will be assessed using standard indices (CFI, RMSEA, SRMR), and factor loadings will be examined to confirm that each item adequately represents its intended construct. SPAS items are scored on an ordinal scale from 0 to 3, where 0 indicates no limitation/best status and 3 indicates the worst level of limitation. Total score will be calculated based on the number of items. The scale will be administered once at baseline to participants who consent to take part in the study.
Measured: 07.2022 and 08.2023. One time.
Secondary outcomes (4)
Internal consistency of the Shoulder Problems Assessment Scale (SPAS)
Internal consistency of SPAS will be evaluated using Cronbach's alpha coefficients calculated for the total scale and each subscale (joint mobility, functionality, and pain) to assess the homogeneity of items within each domain.
Measured: Baseline
Test-retest reliability of the Shoulder Problems Assessment Scale (SPAS)
Test-retest reliability of SPAS will be assessed using intraclass correlation coefficients (ICC). The scale will be re-administered to participants with stable clinical status after a 3-7 day interval to evaluate score stability over time.
Measured: 3-7 days after baseline assessment
Concurrent validity of the Shoulder Problems Assessment Scale (SPAS)
Concurrent validity will be examined by analyzing correlations between SPAS total and subscale scores and the corresponding scores of the Shoulder Pain and Disability Index (SPADI).
Measured: Baseline
Discriminative ability and cut-off value of the Shoulder Problems Assessment Scale (SPAS)
Discriminative ability of the SPAS total score will be evaluated using receiver operating characteristic (ROC) analysis based on a SPADI-derived functional limitation reference. Area under the curve, sensitivity, specificity, and an optimal cut-off value will be determined.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Sep 2023
- Primary completion1 Jun 2024
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder LesionsStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Husamettin Kocak, Suleyman Demirel University
- Investigators
- Ertuğrul Demirdel, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391516
- Sponsor's protocol ID
- SDU-HusamettinKocak-01
- Status last verified
- Jan 2026
- First submitted
- 14 May 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Psychometric Validation of the Shoulder Problems Assessment Scale: A Culturally Grounded Patient-Reported Outcome Measure With a Hierarchical Stepwise Yes/No Response Format
- ClinicalTrials.gov ID
- NCT05391516
- Acronym / sponsor ID
- SDU-HusamettinKocak-01
- Conditions
- Shoulder Lesions, Shoulder Injuries, Shoulder Pain
- Keywords
- Shoulder Pain, Shoulder Activity, Shoulder Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 26 May 2022 (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 purpose of this study is to develop and psychometrically validate the Shoulder Problems Assessment Scale (SPAS), a culturally grounded patient-reported outcome measure designed to assess shoulder-related functional limitations in Turkish adults using a hierarchical stepwise yes/no response format. SPAS items are structured as four ordered difficulty thresholds for common daily activities, allowing respondents to indicate the point at which difficulty first begins while keeping the response task cognitively simple.
Scale development followed a four-stage process including literature review, semi-structured patient interviews, expert content validation (Lawshe method), pilot testing, and main field testing in multiple physical therapy units across Turkey. In the main application, SPAS was administered to individuals with shoulder problems and evaluated for construct validity using exploratory and confirmatory factor analyses, reliability using internal consistency and test-retest intraclass correlation coefficients (3-7 days), and concurrent validity through correlation with the Shoulder Pain and Disability Index (SPADI). Receiver operating characteristic (ROC) analysis was performed to derive a clinically interpretable SPAS cut-off value using a SPADI-based functional limitation reference. The study aims to provide a valid, reliable, practical, and culturally appropriate PROM that can be used in routine clinical assessment and research in Turkey.
Detailed description
This study was designed to develop and psychometrically validate the Shoulder Problems Assessment Scale (SPAS), a patient-reported outcome measure intended to assess shoulder-related functional limitations in adults. SPAS was developed to address limitations of existing shoulder scales related to cognitive burden, cultural relevance, and response format, particularly in populations with varying health literacy levels.
The development process followed a four-stage methodological framework. In the first stage, the conceptual framework and initial item pool were established through a comprehensive literature review, semi-structured interviews with patients experiencing shoulder problems, and input from experienced physical therapists. These steps aimed to identify daily activities that commonly provoke functional difficulty in routine life. An initial pool of 34 items was generated, including activity-based items structured in a hierarchical stepwise yes/no format.
In the second stage, content validity was evaluated by an expert panel using the Lawshe method. Items with insufficient content validity or conceptual overlap were revised, combined, or removed. A pilot study was then conducted to assess item clarity, cultural appropriateness, and comprehensibility. Based on expert feedback and pilot results, the item pool was refined and prepared for the main application.
The third stage consisted of a multicenter field application conducted in physical therapy units across multiple regions of Turkey. SPAS was administered to individuals with shoulder problems, followed by the Turkish version of the Shoulder Pain and Disability Index (SPADI) for concurrent validity assessment. A subgroup of participants with stable clinical status completed SPAS again after 3-7 days to evaluate test-retest reliability.
In the final stage, psychometric analyses were performed. Construct validity was examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) with a robust diagonally weighted least squares estimator appropriate for the hierarchical response structure. Reliability was assessed using internal consistency coefficients and intraclass correlation coefficients. Concurrent validity was evaluated through correlations with SPADI scores. Receiver operating characteristic (ROC) analysis was conducted to determine a clinically interpretable cut-off value for SPAS using a SPADI-derived functional limitation reference.
SPAS consists of 12 activity-based items, each comprising four ordered difficulty levels. Respondents indicate the level at which difficulty first appears, reflecting a threshold-based approach to functional limitation rather than graded symptom intensity. Total scores range from 0 to 48, with higher scores indicating greater functional limitation. The study aims to provide a valid, reliable, and practical instrument for assessing shoulder-related functional limitations in clinical and research settings.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Evaluation of shoulder problemsParticipants; 18-80 years old, who volunteered to participate in the study, patients with shoulder problems. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults aged 18-80 years with shoulder-related pain and/or functional limitation who were referred to or receiving care in physical therapy and rehabilitation units across multiple regions of Turkey. Participants represent a heterogeneous clinical spectrum of shoulder conditions, including rotator cuff-related disorders, adhesive capsulitis, traumatic shoulder lesions, and degenerative conditions. Individuals were recruited from multiple clinical centers to ensure diversity in demographic and clinical characteristics. All participants provided written and verbal informed consent prior to participation.
Key inclusion criteria (1 listed)
- Adults aged 18-80 years Presence of shoulder-related pain and/or functional limitation Referred to or receiving treatment in a physical therapy or rehabilitation unit Ability to understand and respond to the questionnaire items Provision of written and verbal informed consent
Key exclusion criteria (1 listed)
- Neurological disorders affecting upper extremity function Systemic inflammatory or rheumatologic diseases involving the shoulder Severe cognitive impairment or psychiatric conditions that may interfere with questionnaire completion Acute trauma or fracture of the shoulder region requiring emergency management Incomplete or incorrectly completed questionnaire forms
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 |
|---|---|---|
| Evaluation of shoulder problemsThe developed items and Shoulder Pain and Disability Index-SPADI will be directed to the participants. | Diagnostic test | All Participants |
Primary outcome
Construct validity of the Shoulder Problems Assessment Scale (SPAS)
Time frame: 07.2022 and 08.2023. One time.
Construct validity of the Shoulder Problems Assessment Scale (SPAS) will be evaluated by examining its factor structure using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). A three-factor model representing joint mobility, functionality, and pain will be tested. Model fit will be assessed using standard indices (CFI, RMSEA, SRMR), and factor loadings will be examined to confirm that each item adequately represents its intended construct. SPAS items are scored on an ordinal scale from 0 to 3, where 0 indicates no limitation/best status and 3 indicates the worst level of limitation. Total score will be calculated based on the number of items. The scale will be administered once at baseline to participants who consent to take part in the study.
4 secondary outcomes
Internal consistency of the Shoulder Problems Assessment Scale (SPAS)
Time frame: Baseline
Test-retest reliability of the Shoulder Problems Assessment Scale (SPAS)
Time frame: 3-7 days after baseline assessment
Concurrent validity of the Shoulder Problems Assessment Scale (SPAS)
Time frame: Baseline
Discriminative ability and cut-off value of the Shoulder Problems Assessment Scale (SPAS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Shoulder Lesions
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
RecruitingObservational study
Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
Rotator Cuff Tear, Rotator Cuff Tears
Recruiting
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
Rotator Cuff Tear, Rotator Cuff Injury
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.
Ertuğrul Demirdel study director
Ankara Yildirim Beyazıt 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 Shoulder Lesions and Shoulder Injuries, run by Suleyman Demirel 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Construct validity of the Shoulder Problems Assessment Scale (SPAS) (time frame: 07.2022 and 08.2023. One time.). 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 6 Jan 2026.