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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03956147
Other study ID # HEK12/224
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2015
Est. completion date April 15, 2019

Study information

Verified date May 2019
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date April 15, 2019
Est. primary completion date January 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Munich Shoulder Questionnaire
Validation and Reability study

Locations

Country Name City State
Turkey Deni?z Kocamaz Gaziantep
Turkey Deniz Kocamaz Gaziantep

Sponsors (2)

Lead Sponsor Collaborator
Hasan Kalyoncu University Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Yao M, Yang L, Cao ZY, Cheng SD, Tian SL, Sun YL, Wang J, Xu BP, Hu XC, Wang YJ, Zhang Y, Cui XJ. Chinese version of the Constant-Murley questionnaire for shoulder pain and disability: a reliability and validation study. Health Qual Life Outcomes. 2017 Se — View Citation

Yuguero M, Huguet J, Griffin S, Sirvent E, Marcano F, Balaguer M, Torner P. Transcultural adaptation, validation and assessment of the psychometric properties of the spanish version of the Western Ontario Shoulder Instability Index questionnaire. Rev Esp — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective and Subjective Items 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 Objective Function 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 weight 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
Secondary Subjective Function 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
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