Developing a New Scale for Evaluating Shoulder Problems

Shoulder Pain Clinical Trial

Official title:

A New Scale Development, Validity and Reliability Study in Evaluating Shoulder Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391516
• Other study ID #: SDU-HusamettinKocak-01
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Suleyman Demirel University
• Contact: Husamettin koçak, 1
• Phone: 05352845740
• Email: husamettinkocak90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Injuries
• Shoulder Lesions
• Shoulder Pain

Intervention

Diagnostic Test:
• Evaluation of shoulder problems
The developed items and Shoulder Pain and Disability Index-SPADI will be directed to the participants.

Locations

Country	Name	City	State
Turkey	Yalvac Devlet Hastanesi	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of shoulder functionality.	With the items in our the scale, we will develop, pain, limitation, function and strength will be measured in shoulder activities that are frequently used in daily life activities.; Our scale is a scale consisting of 0-3 0 being the best and 3 being the worse pain ever. When the number of items is determined, the total scoring will be determined. Patients participating in the study will be administered the scale once at any time they accept to participate in the study.; We will compare our results with The Shoulder Pain and Disability Index results. The Shoulder Pain and Disability Index is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever.; The Shoulder Pain and Disability Index will be applied after our scale.	Anytime between 07.2022 and 08.2023. One time.