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NCT Number: NCT04716855

Evaluation of Functional Status, Physical Activity and Quality of Life 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).

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of life and daily living activities assessment tests

Other

Primary outcomes

  1. Visual Analog Scale

    Time frame: 2 min

    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. The Shortened Disabilities of the Arm, Shoulder and Hand Score

    Time frame: 10 min

    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.

  3. Short Form-36 (SF-36)

    Time frame: 10 min

    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).

  4. International Physical Activity Questionnaire (IPAQ)

    Time frame: 10 min

    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.

Secondary outcomes

  1. Manual Muscle Test

    Time frame: 10 min

    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.

  2. Range of Motion

    Time frame: 10 min

    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).

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Evaluation of Daily Life Activities in Patients With Rotator Cuff Syndrome

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2021
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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