Establishing Clinical Significance in Rotator Cuff Disease | NCT06677320

Studies
Establishing Clinical Significance in Rotator Cuff Disease

NCT06677320

Sponsor

Kırklareli University

Status

Recruiting

Last Update Posted

Mar 4, 2025Actual

Enrollment

69Estimated

Phase

Not provided

Conditions

Rotator Cuff Disease

Interventions

Exercise

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2025Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Nov 4, 2024

First Submission Date that Met QC Criteria

Nov 5, 2024

First Posted Date

Nov 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2025

Last Update Posted Date

Mar 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ozan Gür, PT, Research Assistant, Kırklareli UniversityPrincipal Investigator

Lead Sponsor

Kırklareli UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotator cuff patients		Patients with rotator cuff disease who will receive conservative treatment.	Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other	Patients with rotator cuff disease will receive exercise treatment for two months.	Rotator cuff patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ozan Gür, MSc	Contact	506 338 38 49	90	ozan.gur94@gmail.com

Overall Officials

Name	Affiliation	Role
Ozan Gür, MSc	Kırklareli University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kırklareli Eğitim ve Araştırma Hastanesi	Recruiting	Kırklareli		39000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided