Clinical trial NCT06677320: Establishing Clinical Significance in Rotator Cuff Disease
Official title: Establishing the Clinical Significance Values of Scales Used in Rotator Cuff Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Disease
Keywords: rotator cuff
clinical significance
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
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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?


Eligibility criteria: 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

Primary outcomes:
measure: Functional level
timeFrame: before the treatment and within 1 week after 2 months of treatment
measure: Functional level
timeFrame: before the treatment and within 1 week after 2 months of treatment
measure: Functional level
timeFrame: before the treatment and within 1 week after 2 months of treatment
measure: Functional level
timeFrame: before the treatment and within 1 week after 2 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Kırklareli University
name: Ozan Gür, MSc
role: PRINCIPAL_INVESTIGATOR
References: