Clinical trial NCT05391516: Developing a New Scale for Evaluating Shoulder Problems
Official title: A New Scale Development, Validity and Reliability Study in Evaluating Shoulder Problems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Lesions
Shoulder Injuries
Shoulder Pain
Keywords: Shoulder Pain
Shoulder Activity
Shoulder Evaluation
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Literate individuals with shoulder problems in Turkey.

Brief summary: Problems related to the shoulder are frequently seen in the society. Many methods are used to evaluate these problems. One of the most frequently used methods is self-report scales. When the shoulder-oriented self-report scales in the literature are examined, methods such as Visual Analog Scale, Numeric Scale and Likert Scale are used more frequently. In the literature, there is no scale that seeks clear answers as yes/no by grading shoulder-oriented activities. We would like to contribute to the literature by developing a scale that uses such a scaling method. All of the shoulder-oriented self-report scales used in Turkey were developed by cultural adaptation. In our study, it was aimed to develop an easy-to-understand scale that includes items with high social intelligibility and offers a new scaling method.

Detailed description: In this study, the scale development process was: identifying the problem, creating the item pool, presenting the item pool to the expert opinion, applying the renewed items to a pilot group after the expert opinion, applying the finalized items to the pilot group if necessary item changes after the pilot application, after the scale items took their final form. It is planned to apply to the main group and report the results.

Identification of the Problem: The lack of a developed scale for the shoulder specific to Turkish society. The absence of the scale in the literature, which received a clear answer with the yes/no method by reviewing the activity.

Item Pool:

In the study, an item pool will be created by analyzing other shoulder scales in the literature, by making a literature review, by taking patient feedback and clinician opinions.

Expert opinion:

The created item pool will be submitted to the evaluation of experts consisting of at least one linguist and physiotherapists. The item pool will be renewed according to the feedback of the experts.

Pilot Application:

The items to be formed after the expert opinion in the study; It will be presented to the opinion of patients between the ages of 18-80 who volunteer to participate in the study and have shoulder problems. It will be applied in isparta yalvac state hospital. Before participating in the study, individuals will be informed about the purpose and content of the study and their written and verbal consent will be obtained. Patients who are illiterate and do not understand what they read will not be included in our study. The answers including age, gender, diagnosis, educational status, dominant side and which side's shoulders are affected will be recorded in the evaluation form. Scale items will continue to be applied to the pilot group until they are finalized.

Main Application:

The population of the study consists of literate individuals with shoulder problems in Turkey. The number of individuals to be included in the study will be calculated according to the number of main items to be formed after the pilot application. It will be applied in 12 state hospitals where official permission is obtained according to Turkey's statistical region classification (nomenclature d'unités territoriales statistiques, NUTS).

Practitioner:

The application of the finalized scale to the patients will be carried out by the clinicians of the hospital for which permission has been obtained. It is thought that blinding these clinicians, who do not know about our scale development processes, to the study will prevent possible bias and increase the quality of our study.

Reporting:

After the statistical analysis made after the main application, a scoring system will be created when the items in the scale take their final form. Similar scale validity method will be used for content validity of the study. To determine the validity of the scale, will use Shoulder Pain and Disability Index-SPADI scale developed by Roach et al.

Eligibility criteria: Inclusion Criteria:

* literate
* 18-80 years old
* who volunteered to participate in the study
* patients with shoulder problems

Exclusion Criteria:

* illiterate
* not willing to participate.

Primary outcomes:
measure: Evaluation of shoulder functionality.
timeFrame: Anytime between 07.2022 and 08.2023. One time.
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Yalvac Devlet Hastanesi
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Ertuğrul Demirdel
role: STUDY_DIRECTOR
References: