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

NCT04716855 | Completed

• 1 other identifier: 10840098-604.01.01-E.4606.
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Rotator Cuff Syndrome

Keywords

Pain; Physical activity; Rotator cuff syndrome; Quality of life

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Manual Muscle Test

  10 min

• Range of Motion

  10 min

Study Arms (1)

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

Interventions

Quality of life and daily living activities assessment tests OTHER

Evaluation tests

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patients presenting with shoulder pain problems and diagnosed with RCS.
• Individuals between the ages of 19-64 were included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Mehmet Salih Tan

  Istanbul Medipol University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 20, 2021
• Study Start: March 25, 2015
• Primary Completion: May 20, 2016
• Study Completion: December 22, 2016
• Last Updated: January 20, 2021

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)