"Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients" (MSQ)

May 17, 2019 updated by: Deniz KOCAMAZ, Hasan Kalyoncu University

Cultural Adaptation, Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients With Shoulder Dysfunction

The purpose of this study was to translate and culturally adapt the MSQ to Turkish language and test the validity and reliability of Turkish version of MSQ in shoulder dysfunction patients. And also, the ultimate goal was to facilitate international researches in shoulder problems as well as to serve the physicians for their clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Munich Shoulder Questionnaire (MSQ) is an innovative tool for self-assessment of shoulder function. It was especially designed for an effective follow-up of shoulder patients which were also allowing for a quantitative assessment of the Constant, Shoulder Pain and Disability Index (SPADI) and DASH score consisting of a 30-items questionnaire. It based on subjective and objective parameters of shoulder function.

Standart questionnaire enable to follow patients on a close and regular base with manageable effort for both the disability and the patients.an optimal instrument for outcome measurement of shoulder problems should meet the following requirments: a) the instrument should be a self-assmment patient reporting tool, b) the questions must be easily comprensible, c) filling in should be finished less than 30 minutes, d) the results should provide calculation of several well established scoring system. MSQ can be completed at home and typical functional abilities about evaluation are explained with pictures so these can make it easy. As a result, we choose to translate the MSQ into Turkish as it is less costly, practical and time consuming than developing a new tool. In addition, objective (normal joint movement and muscle strength) and subjective (pain, daily life activity, sport and leisure time activities) parameters in a single form to create the advantage in terms of ease of use and time. With these properties, MSQ may be preferred during follow-up of the results of conservative and / or surgical treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27410
        • Deni̇z Kocamaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

shoulder dysfunction

Description

Inclusion Criteria:

  • being between 18-65 years old,
  • having unilateral or bilateral shoulder dysfunction,
  • ability to read and complete the self-assessment questionnaires

Exclusion Criteria:

  • have neurological, psychological and cardiovasculer diseases or injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective and Subjective Items
Time Frame: 2 days
The Munich Shoulder Questionnaire is a 30-items self-assessment questionnaire. Its raw score ranges from 0 to 314. For comparability, the raw numbers are divided by 314 giving a percentage ranging from 0 to 100 in which higher scores represent a better function of the shoulder.
2 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Function
Time Frame: 2 days
The objective function of the shoulder and consists of six items. The first five questions assess the range of motion: flexion, abduction, internal rotation, external rotation and range of the hand. Each question offer result from 0 to 10 points resulting in a total score ranging from a minimum of 0 to a maximum of 50 points ( 16 % of totals of MSQ) . The 6th targets at the power of the shoulder in 90° of abduction and 20° of quested to lift flexion. The patient is asked to fill a bag with items of daily living with a defined weıght such as a 500 gr water plastic bottle or bag. Then the patient is requested to lift the bag to the horizontal plane and hold 5 seconds. This is performed stepwise with increasing weights until the 12 kg. Each 500 gr is 2 point and maximum points is 24 for this question.(8%of the total MSQ).Altogether the objective part is a total score ranging from 0 to 74 points (%24 of the MSQ).
2 days
Subjective Function
Time Frame: 2 days
subjective function and consists of 24 items. Six of the items deal with pain, nine cover work and activities of daily living, six cover sports and recreation activities and three ask for the social and emotional quality of life. This section accounts for a total score ranging from 0 to 240 points (%76 of the MSQ). It raw score ranges from 0 to 314. For comparability, the raw numbers are divided by 314 giving a percentage ranging from 0 to 100 in which higher scores represent a better function of shoulder
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gamze Ekici, Prof., Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEK12/224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients

IPD Sharing Time Frame

3 months

IPD Sharing Access Criteria

18-65 years Having shoulder problem

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings