Development a New Scale for Assessment Shoulder Problems

NCT05391516 | Completed

• 1 other identifier: SDU-HusamettinKocak-01
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shoulder Lesions; Shoulder Injuries; Shoulder Pain

Keywords

Shoulder Pain; Shoulder Activity; Shoulder Evaluation

Outcome Measures

Primary Outcomes (1)

• 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.

  07.2022 and 08.2023. One time.

Secondary Outcomes (4)

• Internal consistency of the Shoulder Problems Assessment Scale (SPAS)

  Baseline

• Test-retest reliability of the Shoulder Problems Assessment Scale (SPAS)

  3-7 days after baseline assessment

• Concurrent validity of the Shoulder Problems Assessment Scale (SPAS)

  Baseline

• Discriminative ability and cut-off value of the Shoulder Problems Assessment Scale (SPAS)

  Baseline

Study Arms (1)

All Participants

Participants; 18-80 years old, who volunteered to participate in the study, patients with shoulder problems.

Diagnostic Test: Evaluation of shoulder problems

Interventions

Evaluation of shoulder problems DIAGNOSTIC_TEST

The developed items and Shoulder Pain and Disability Index-SPADI will be directed to the participants.

All Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Yalvac Devlet Hastanesi

Isparta, 32000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ertuğrul Demirdel

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 26, 2022
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 16, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)