Establishing Clinical Significance in Rotator Cuff Disease

Establishing the Clinical Significance Values of Scales Used in Rotator Cuff Disease

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?

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Disease
• Intervention / Treatment: Other: Exercise

• Study Type: Observational
• Enrollment (Estimated): 69

Contacts and Locations

• Study Contact: Name: Ozan Gür, MSc; Phone Number: 90 506 338 38 49; Email: ozan.gur94@gmail.com

Study Locations

• Turkey
  • Kırklareli, Turkey, 39000
    • Recruiting
    • Kırklareli Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted with rotator cuff patients who will have physical therapy at Kırklareli Training and Research Hospital's physical therapy unit.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rotator cuff patients; Patients with rotator cuff disease who will receive conservative treatment.	Other: Exercise; Patients with rotator cuff disease will receive exercise treatment for two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional level	Shoulder Disability Questionnaire (total score between 0-100) (higher values indicate higher disability)	before the treatment and within 1 week after 2 months of treatment
Functional level	The short version of the Western Ontario Rotator Cuff Index (total score between 0-100) (higher values indicate higher functional level)	before the treatment and within 1 week after 2 months of treatment
Functional level	Shoulder Rating Questionnaire (total score between 17-100) (higher values indicate higher functional level)	before the treatment and within 1 week after 2 months of treatment
Functional level	The University of California-Los Angeles Shoulder Scale (total score between 0-100) (higher values indicate higher functional level)	before the treatment and within 1 week after 2 months of treatment

Collaborators and Investigators

• Sponsor: Kırklareli University
• Investigators: Principal Investigator: Ozan Gür, MSc, Kırklareli University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: clinical significance; rotator cuff; minimal important chance; substantial clinical benefit; patient acceptable symptomatic state; maximal outcome improvement; Shoulder Disability Questionnaire; Western Ontario Rotator Cuff Index; Shoulder Rating Questionnaire; University of California-Los Angeles Shoulder Scale
• Other Study ID Numbers: 2024-1636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No