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

Evaluation of Daily Life Activities in Patients With Rotator Cuff Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Syndrome
• Intervention / Treatment: Other: Quality of life and daily living activities assessment tests

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Istanbul Medipol University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study was applied patients which were diagnosed with RC syndrome the Physical Therapy and Rehabilitation Department at Istanbul Medipol Mega University Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Evaluation tests; RCS cases between the ages of 19-64 (n:40) who agreed to participate were included in the study. Pain severity (Visual Analogue Scale - VAS), range of motion (Universal Goniometer), muscle test (Manual muscle test), upper extremity functional status and disability (Quick-DASH questionnaire), physical activity level (International Physical Activity Questionnaire - UFAA) ) and quality of life (Short Form-36 - SF-36) were evaluated

Other: Quality of life and daily living activities assessment tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Koçyiğit 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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-İR) are scored by scoring between 0 and 5 in manual muscle test.	10 min
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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Mehmet Salih Tan, Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start: March 25, 2015
• Primary Completion (Actual): May 20, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Physical activity; Rotator cuff syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries
• Other Study ID Numbers: 10840098-604.01.01-E.4606.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No