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NCT Number: NCT06677320

Establishing Clinical Significance 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?

Recruiting

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Key information

Conditions

Rotator Cuff Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kırklareli Eğitim ve Araştırma Hastanesi

Kırklareli, 39000, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Patients with rotator cuff disease will receive exercise treatment for two months.

Primary outcomes

  1. Functional level

    Time frame: before the treatment and within 1 week after 2 months of treatment

    Shoulder Disability Questionnaire (total score between 0-100) (higher values indicate higher disability)

  2. Functional level

    Time frame: before the treatment and within 1 week after 2 months of treatment

    The short version of the Western Ontario Rotator Cuff Index (total score between 0-100) (higher values indicate higher functional level)

  3. Functional level

    Time frame: before the treatment and within 1 week after 2 months of treatment

    Shoulder Rating Questionnaire (total score between 17-100) (higher values indicate higher functional level)

  4. Functional level

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ozan Gür, MSc

CONTACT

[email protected]

506 338 38 49 ext. 90

Sponsors and collaborators

Lead sponsor

Kırklareli University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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