Rotator Cuff TearsNCT05266352
Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff Tears
A study testing Supervised exercise program and Home exercise program in people with Rotator Cuff Tears and Pain, Shoulder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Rotator Cuff Tears, Pain, Shoulder, Psychological
- What is being tested?
- Supervised exercise program and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 14 Feb 2024
- Phase
- Interventional
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: Forty years of age or older patients that have been diagnosed for a partial rotator cuff tear that is unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder will be included into this study.
Exclusion Criteria: Patients diagnosed with full-thickness or massive rotator cuff tear, patients who undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear will not be included into this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, 34147
About this study
Official title: Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears.
Read the detailed description
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Fifty voluntary patients with partial rotator cuff tear will be randomized into two groups: Supervised exercise group (SE) and home exercise (HE) group, for a standardized 8 weeks exercise program. The primary outcome is the Constant-Murley Score (CMS). The secondary outcomes are the Visual Analogue Scale (VAS), active range of motion (AROM), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSI), Short Form-12 (SF-12), and Global Rating of Change (GRC). Outcome measures will be performed at baseline and at the end of 8-week intervention.
- Conditions
- Rotator Cuff Tears, Pain, Shoulder, Psychological
- Being tested
- Supervised exercise program, Home exercise program
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programOther
A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks.
Patients will do the exercises under control of the physiotherapist in the clinic.
Home exercise programDiagnostic test
A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks.
Patients will do the exercises at home. Patients will visit the clinic every 2 weeks and progression of exercise program will be made.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise group | Experimental | The group received the supervised exercise program Receives: Other: Supervised exercise program |
| Home exercise group | Active comparator | The group received the home exercise program Receives: Diagnostic Test: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Score
The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
Measured: Baseline
Secondary outcomes (15)
Constant-Murley Score
The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
Measured: At the end of 8-week intervention
Visual Analogue Scale (VAS)
Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
Measured: Baseline
Visual Analogue Scale (VAS)
Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
Measured: At the end of 8-week intervention
Active Range of Motion (AROM) Assessment
The shoulder flexion, abduction, internal and external rotation ROM will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer. The process will be repeated three times in each direction, with the average value recorded.
Measured: Baseline
Active Range of Motion (AROM) Assessment
The shoulder flexion, abduction, internal and external rotation ROM will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer. The process will be repeated three times in each direction, with the average value recorded.
Measured: At the end of 8-week intervention
Pain Catastrophizing Scale (PCS)
Pain catastrophizing, which is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event will be measured using the Pain Catastrophizing Scale (PCS).
Measured: Baseline
Pain Catastrophizing Scale (PCS)
Pain catastrophizing, which is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event will be measured using the Pain Catastrophizing Scale (PCS).
Measured: At the end of the 8-week intervention
The Hospital Anxiety and Depression Scale (HADS)
The anxiety and depression will be assessed using the Pain Catastrophizing Scale (PCS), which is used to measure anxiety and depression in a general medical population of patients.
Measured: Baseline
The Hospital Anxiety and Depression Scale (HADS)
The anxiety and depression will be assessed using the Pain Catastrophizing Scale (PCS), which is used to measure anxiety and depression in a general medical population of patients.
Measured: At the end of the 8-week intervention
Pittsburgh Sleep Quality Index (PSQI)
The anxiety and depression will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
The anxiety and depression will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Measured: At the end of the 8-week intervention
Short Form-12 (SF-12)
Health related quality of life will be assessed using the SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Measured: Baseline
Short Form-12 (SF-12)
Health related quality of life will be assessed using the SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Measured: At the end of the 8-week intervention
Global Rating of Change (GRC)
Patient satisfaction regarding improvement in shoulder function will be assessed by the Global Rating of Change (GRC) scale. The patients will be asked to rate their condition after a 8-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.
Measured: At the end of the 8-week intervention
Exercise Dairy
A self reported adherence to home exercise program will be assessed using the exercise dairy.
Measured: At the end of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start28 Feb 2022
- Primary completion28 Feb 2023
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
- Investigators
- Tansu Birinci, PT, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266352
- Sponsor's protocol ID
- 108
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff
- ClinicalTrials.gov ID
- NCT05266352
- Acronym / sponsor ID
- 108
- Conditions
- Rotator Cuff Tears, Pain, Shoulder, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 4 Mar 2022 (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.
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears.
Detailed description
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Fifty voluntary patients with partial rotator cuff tear will be randomized into two groups: Supervised exercise group (SE) and home exercise (HE) group, for a standardized 8 weeks exercise program. The primary outcome is the Constant-Murley Score (CMS). The secondary outcomes are the Visual Analogue Scale (VAS), active range of motion (AROM), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSI), Short Form-12 (SF-12), and Global Rating of Change (GRC). Outcome measures will be performed at baseline and at the end of 8-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise group | Experimental | Other: Supervised exercise programThe group received the supervised exercise program |
| Home exercise group | Active comparator | Diagnostic Test: Home exercise programThe group received the home exercise program |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Supervised exercise programA structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks. Patients will do the exercises under control of the physiotherapist in the clinic. | Other | Supervised exercise group |
| Home exercise programA structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks. Patients will do the exercises at home. Patients will visit the clinic every 2 weeks and progression of exercise program will be made. | Diagnostic test | Home exercise group |
Primary outcome
Constant-Murley Score
Time frame: Baseline
The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
15 secondary outcomes
Constant-Murley Score
Time frame: At the end of 8-week intervention
Visual Analogue Scale (VAS)
Time frame: Baseline
Visual Analogue Scale (VAS)
Time frame: At the end of 8-week intervention
Active Range of Motion (AROM) Assessment
Time frame: Baseline
Active Range of Motion (AROM) Assessment
Time frame: At the end of 8-week intervention
Pain Catastrophizing Scale (PCS)
Time frame: Baseline
Pain Catastrophizing Scale (PCS)
Time frame: At the end of the 8-week intervention
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
The Hospital Anxiety and Depression Scale (HADS)
Time frame: At the end of the 8-week intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At the end of the 8-week intervention
Short Form-12 (SF-12)
Time frame: Baseline
Short Form-12 (SF-12)
Time frame: At the end of the 8-week intervention
Global Rating of Change (GRC)
Time frame: At the end of the 8-week intervention
Exercise Dairy
Time frame: At the end of the 8-week intervention
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 8 Oct 2024.
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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.
Tansu Birinci, PT, PhD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise program and Home exercise program in people with Rotator Cuff Tears and Pain, Shoulder, run by Istanbul University - Cerrahpasa 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?
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 8 Oct 2024. 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?
Constant-Murley Score (time frame: Baseline). 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 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.