Shoulder ImpingementMSQNCT03956147
"Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients"
An observational study of Shoulder Impingement and Shoulder Pain, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement, Shoulder Pain, Shoulder Injury
- What is being tested?
- Munich Shoulder Questionnaire
- How many people
- 180 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2015to 15 Apr 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: shoulder dysfunction
Who may be able to join
- being between 18-65 years old,
- having unilateral or bilateral shoulder dysfunction,
- ability to read and complete the self-assessment questionnaires
Who cannot join
- have neurological, psychological and cardiovasculer diseases or injuries
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Deniz Kocamaz
Gaziantep, 27410
Deni̇z Kocamaz
Gaziantep, 27410
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Impingement, Shoulder Pain, Shoulder Injury
- Being tested
- Munich Shoulder Questionnaire
- Keywords
- Cultural adaptation, validation, responsibility, shoulder
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Munich Shoulder QuestionnaireOther
Also called Disability of arm, shoulder and hand, shoulder pain and disability index
Validation and Reability study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (2)
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 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).
Measured: 2 days
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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Apr 2015
- Primary completion15 Jan 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Deniz KOCAMAZ, Hasan Kalyoncu University
- Investigators
- Gamze Ekici, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956147
- Sponsor's protocol ID
- HEK12/224
- Acronym
- MSQ
- Status last verified
- May 2019
- First submitted
- 16 Apr 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients
Publications
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 Sep 18;15(1):178. doi: 10.1186/s12955-017-0752-3.
PubMed 28923113Yuguero 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 Cir Ortop Traumatol. 2016 Nov-Dec;60(6):335-345. doi: 10.1016/j.recot.2016.07.003. Epub 2016 Aug 21. English, Spanish.
PubMed 27553522
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation, Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients With Shoulder Dysfunction
- ClinicalTrials.gov ID
- NCT03956147
- Acronym / sponsor ID
- MSQ / HEK12/224
- Conditions
- Shoulder Impingement, Shoulder Pain, Shoulder Injury
- Keywords
- Cultural adaptation, validation, responsibility, shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- shoulder dysfunction
Key inclusion criteria (3 listed)
- being between 18-65 years old,
- having unilateral or bilateral shoulder dysfunction,
- ability to read and complete the self-assessment questionnaires
Key exclusion criteria (1 listed)
- have neurological, psychological and cardiovasculer diseases or injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Munich Shoulder QuestionnaireAlso: Disability of arm, shoulder and hand, shoulder pain and disability indexValidation and Reability study | Other | – |
Primary outcome
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 secondary outcomes
Objective Function
Time frame: 2 days
Subjective Function
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Results publication: PubMed 28923113Yao 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 Sep 18;15(1):178. doi: 10.1186/s12955-017-0752-3.
- Results publication: PubMed 27553522Yuguero 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 Cir Ortop Traumatol. 2016 Nov-Dec;60(6):335-345. doi: 10.1016/j.recot.2016.07.003. Epub 2016 Aug 21. English, Spanish.
- Individual participant dataSharing planned: Yes. Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients
Related trials for Shoulder Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Ekici, Prof. study director
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Impingement and Shoulder Pain, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective and Subjective Items (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956147, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.