Establishing Clinical Significance in Rotator Cuff Disease

Recruiting

• Conditions: Rotator Cuff Disease

• Registration Number: NCT06677320
• Lead Sponsor: Kırklareli University

Brief Summary

The goal of this observational study is to learn about rotator cuff patients. The main questions it aims to answer are:

* What is the minimal clinically important difference value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?

* What is the substantial clinical benefit value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?

* What is the patient-acceptable symptomatic state value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?

* What is the maximal outcome improvement value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?

* What are the risk factors that prevent rotator cuff patients from reaching the minimal clinically important difference value?

* What are the risk factors that prevent rotator cuff patients from reaching the substantial clinical benefit value?

* What are the risk factors that prevent rotator cuff patients from reaching the patient-acceptable symptomatic state value?

* What are the risk factors that prevent rotator cuff patients from reaching the maximal outcome improvement value?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-06
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• to be over 18 years old
• to be a rotator cuff patient

Exclusion Criteria

• to have another pathology in the affected shoulder area
• to have a neurological, rheumatological, or oncological disease
• to have radiculopathy
• to have had a previous fracture or operation in the affected shoulder area
• to be not cooperative enough for what will be done within the scope of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional level	before the treatment and within 1 week after 2 months of treatment	The University of California-Los Angeles Shoulder Scale (total score between 0-100) (higher values indicate higher functional level)

Trial Locations

Locations (1)

Kırklareli Eğitim ve Araştırma Hastanesi; 🇹🇷 Kırklareli, Turkey