Evaluation of Functional Status, Physical Activity and Quality of Life in Patients With Rotator Cuff Syndrome

Rotator Cuff Syndrome Clinical Trial

Official title:

Evaluation of Daily Life Activities in Patients With Rotator Cuff Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716855
• Other study ID #: 10840098-604.01.01-E.4606.
• Status: Completed
• Start date: March 25, 2015
• Est. completion date: December 22, 2016

Study information

• Verified date: March 2015
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Pain is one of the most important factors affecting the quality of life. The quality of life of patients with pain and restricted shoulder movements can be affected in patients with Rotator Cuff Syndrome (RCS).

Description:

The aim of our study is to examine the effect of the pain on functional status, quality of life and physical activity levels in daily life activities of RCS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 22, 2016
• Est. primary completion date: May 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients presenting with shoulder pain problems and diagnosed with RCS.

• Individuals between the ages of 19-64 were included in the study.

Exclusion Criteria:

• Those who have mental disability at the level of understanding the test and preventing interviews.

• Those with any chronic problems (such as cancer, kidney failure)

• Those who receive special medical treatment (steroid therapy, chemotherapy, insulin use.)

• Those who had a pregnancy status were excluded from the study.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Syndrome
• Syndrome

Intervention

Other:
• Quality of life and daily living activities assessment tests

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically to digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. In this study, the severity of pain was questioned as 1- Night pain 2- Rest pain 3- Activity pain 4- Lift pain and it was marked separately for each situation.	2 min
Primary	The Shortened Disabilities of the Arm, Shoulder and Hand Score	The "Quick-DASH" (The Disabilities of the Arm, Shoulder and Hand Score) questionnaire, which is the short form of the "DASH" questionnaire, was used to determine the level of activity and engagement from the upper side. The Turkish reliability and validity study of the questionnaire was carried out by Düger et al.. Each answer is scored from 1 to 5 from good to bad; 1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not being able to do it at all. A score between 0-100 (0 = no disability, 100 = maximum disability) is obtained from each part of the Quick-DASH questionnaire.	10 min
Primary	Short Form-36 (SF-36)	Short Form SF-36 was used to evaluate the quality of life. SF-36 consists of 8 sub-dimensions consisting of 36 items in which physical and mental health is evaluated. The Turkish reliability and validity study of the questionnaire was carried out by Koçyigit et al. [21]. There are two main subsections belonging to SF-36. In the physical health components subsection are included Physical function (PF), physical role (PR), body pain (BP) and general health status (GHS) sub-dimensions. Sub-dimensions related to mental health status are stated as vitality (VT), social function (SF), emotional role (RE), and mental health (MH).	10 min
Primary	International Physical Activity Questionnaire (IPAQ)	It has been explained that IPAQ is a safe and valid application in determining physical activity. The Turkish reliability and validity study of the questionnaire was carried out by Ozturk.; The questionnaire consists of 4 separate sections and includes 7 questions in total. This questionnaire includes questions about physical activity for a minimum of 10 minutes in the last 7 days.	10 min
Secondary	Manual Muscle Test	Shoulder flexion (Muscle (M)-FL), abduction (M-AB), extension (M-EX), adduction (M-AD), external rotation (M-ER) and internal rotation (M-IR) are scored by scoring between 0 and 5 in manual muscle test.	10 min
Secondary	Range of Motion	Flexion, extension, abduction, adduction, internal rotation and external rotation range of motion were measured with a universal goniometer for the shoulder joint. The measurement values were recorded in degrees. Normal values for shoulder range of motion are 0-180º in flexion (FL) and abduction (AB), 0-45º in extension (EX) and adduction (AD), 0-90º in external rotation (ER) and 0-70º in internal rotation (IR).	10 min