Establishing Clinical Significance in Rotator Cuff Disease

NCT06677320 | Recruiting

• 1 other identifier: 2024-1636
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Rotator cuff patients

Patients with rotator cuff disease who will receive conservative treatment.

Other: Exercise

Interventions

Exercise OTHER

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

Rotator cuff patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

Kırklareli Eğitim ve Araştırma Hastanesi

Kırklareli, 39000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ozan Gür, MSc

  Kırklareli University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozan Gür, MSc

CONTACT

506 338 38 49; ozan.gur94@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

TU (1)