Rotator Cuff SyndromeNCT04716855
Evaluation of Functional Status, Physical Activity and Quality of Life in Patients With Rotator Cuff Syndrome
An observational study of Rotator Cuff Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Quality of life and daily living activities assessment tests
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2015to 22 Dec 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Patients presenting with shoulder pain problems and diagnosed with RCS.
- Individuals between the ages of 19-64 were included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, 34000
About this study
Official title: 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).
Read the 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.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Quality of life and daily living activities assessment tests
- Keywords
- Pain, Physical activity, Rotator cuff syndrome, Quality of life
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life and daily living activities assessment testsOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Quality of life and daily living activities assessment tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 10 min
Secondary outcomes (2)
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.
Measured: 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).
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start25 Mar 2015
- Primary completion20 May 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Salih Tan, Principal investigator, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716855
- Sponsor's protocol ID
- 10840098-604.01.01-E.4606.
- Status last verified
- Mar 2015
- First submitted
- 16 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily Life Activities in Patients With Rotator Cuff Syndrome
- ClinicalTrials.gov ID
- NCT04716855
- Acronym / sponsor ID
- 10840098-604.01.01-E.4606.
- Conditions
- Rotator Cuff Syndrome
- Keywords
- Pain, Physical activity, Rotator cuff syndrome, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2015
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation tests | – | Other: Quality of life and daily living activities assessment testsRCS 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 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Patients presenting with shoulder pain problems and diagnosed with RCS.
- Individuals between the ages of 19-64 were included in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life and daily living activities assessment tests | Other | Evaluation tests |
Primary outcome
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.
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.
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).
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.
2 secondary outcomes
Manual Muscle Test
Time frame: 10 min
Range of Motion
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Salih Tan principal investigator
Istanbul Medipol University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 2 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.