Rotator Cuff TearsNCT05266339
Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
A study testing Cross-education training and Standard 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 randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Pain, Shoulder, Surgery
- What is being tested?
- Cross-education training and Standard exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2022to 15 Aug 2025
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish
Who cannot join
- Revision surgery or previous shoulder surgery Having undergone subscapularis tendon repair in addition to arthroscopic rotator cuff repair Having scoliosis surgery or a health problem that will cause limitation in spinal mobility Restriction of movement or absence of limb in the opposite upper extremity Having frozen shoulder Presence of glenohumeral instability Having been diagnosed with thoracic outlet syndrome Presence of upper extremity fracture or tumor Having been diagnosed with cervical radiculopathy Having been diagnosed with any malignant condition, systemic, neurological or rheumatological disease Having a skin disease or hearing-vision problem that will affect the evaluation process
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, 34147
About this study
This randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.
Read the detailed description
Fifty voluntary patients who underwent arthroscopic rotator cuff repair, aged between 35-64 years will be randomly divided into two groups: Cross-education group and standard rehabilitation group. Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline, at the end of the 8-week intervention and 1-month follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status will be evaluated by Constant-Murley Score (CMS) and American Shoulder and Elbow Surgeons (ASES) Score. Health-related quality of life will be assessed with Short Form-12 (SF-12). The Global Rating of Change will be used to evaluate patient satisfaction.
- Conditions
- Rotator Cuff Tears, Pain, Shoulder, Surgery
- Being tested
- Cross-education training, Standard 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.
Cross-education trainingOther
The strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side.
Standard exercise programOther
The standard exercise program, which prepared according to The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair, will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Cross-education group | Experimental | Each subject in the cross-education group will receive a treatment protocol consisting of cross-education (training of the contralateral limb) and standard exercise program applied after arthroscopic rotator cuff repair. Receives: Other: Cross-education training; Other: Standard exercise program |
| Standard exercise group | Active comparator | Each subject in the standard exercise group will receive a treatment protocol consisting of standard exercise program applied after arthroscopic rotator cuff repair. Receives: Other: Standard 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 (17)
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
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: 1-month follow-up after intervention
Visual Analogue Scale
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
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
Visual Analogue Scale
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: 1-month follow-up after intervention
Active Range of Motion Assessment
The shoulder flexion, abduction, internal and external rotation range of motion 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 Assessment
The shoulder flexion, abduction, internal and external rotation range of motion 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 the 8-week intervention
Active Range of Motion Assessment
The shoulder flexion, abduction, internal and external rotation range of motion 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: 1-month follow-up after intervention
Muscle Strength
Isometric muscle strength will be measured with a handheld dynamometer for shoulder flexion, abduction, internal and external rotation. The process will be repeated three times in each direction, with the average value recorded.
Measured: At the end of the 8-week intervention
Muscle Strength
Isometric muscle strength will be measured with a handheld dynamometer for shoulder flexion, abduction, internal and external rotation. The process will be repeated three times in each direction, with the average value recorded.
Measured: 1-month follow-up after intervention
American Shoulder and Elbow Surgeons Shoulder Score
The functional level will be measured using the American Shoulder and Elbow Surgeons Shoulder Score (ASES), which is created by the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures and to promote multicenter trials in shoulder and elbow surgery. This score contains a physician-rated and patient-rated section. The total score - 100 maximum points - is weighted 50% for pain and 50% for function.
Measured: Baseline
American Shoulder and Elbow Surgeons Shoulder Score
The functional level will be measured using the American Shoulder and Elbow Surgeons Shoulder Score (ASES), which is created by the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures and to promote multicenter trials in shoulder and elbow surgery. This score contains a physician-rated and patient-rated section. The total score - 100 maximum points - is weighted 50% for pain and 50% for function.
Measured: At the end of the 8-week intervention
American Shoulder and Elbow Surgeons Shoulder Score
The functional level will be measured using the American Shoulder and Elbow Surgeons Shoulder Score (ASES), which is created by the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures and to promote multicenter trials in shoulder and elbow surgery. This score contains a physician-rated and patient-rated section. The total score - 100 maximum points - is weighted 50% for pain and 50% for function.
Measured: 1-month follow-up after intervention
Short Form-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
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
Short Form-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: 1-month follow-up after intervention
Global Rating of Change
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
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 start9 May 2022
- Primary completion15 Aug 2024
- Study completion15 Aug 2025 (estimated)
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
- 50 participants (estimated)
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
- NCT05266339
- Sponsor's protocol ID
- 109
- Status last verified
- Jun 2024
- First submitted
- 28 Feb 2022
- Last updated
- 20 May 2025
- 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05266339
- Acronym / sponsor ID
- 109
- Conditions
- Rotator Cuff Tears, Pain, Shoulder, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2025 (estimated)
- 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 randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.
Detailed description
Fifty voluntary patients who underwent arthroscopic rotator cuff repair, aged between 35-64 years will be randomly divided into two groups: Cross-education group and standard rehabilitation group. Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline, at the end of the 8-week intervention and 1-month follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status will be evaluated by Constant-Murley Score (CMS) and American Shoulder and Elbow Surgeons (ASES) Score. Health-related quality of life will be assessed with Short Form-12 (SF-12). The Global Rating of Change will be used to evaluate patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-education group | Experimental | Other: Cross-education training, Other: Standard exercise programEach subject in the cross-education group will receive a treatment protocol consisting of cross-education (training of the contralateral limb) and standard exercise program applied after arthroscopic rotator cuff repair. |
| Standard exercise group | Active comparator | Other: Standard exercise programEach subject in the standard exercise group will receive a treatment protocol consisting of standard exercise program applied after arthroscopic rotator cuff repair. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish
Key exclusion criteria (1 listed)
- Revision surgery or previous shoulder surgery Having undergone subscapularis tendon repair in addition to arthroscopic rotator cuff repair Having scoliosis surgery or a health problem that will cause limitation in spinal mobility Restriction of movement or absence of limb in the opposite upper extremity Having frozen shoulder Presence of glenohumeral instability Having been diagnosed with thoracic outlet syndrome Presence of upper extremity fracture or tumor Having been diagnosed with cervical radiculopathy Having been diagnosed with any malignant condition, systemic, neurological or rheumatological disease Having a skin disease or hearing-vision problem that will affect the evaluation process
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 |
|---|---|---|
| Cross-education trainingThe strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side. | Other | Cross-education group |
| Standard exercise programThe standard exercise program, which prepared according to The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair, will be applied. | Other | Cross-education group, Standard 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.
17 secondary outcomes
Constant-Murley Score
Time frame: At the end of 8-week intervention
Constant-Murley Score
Time frame: 1-month follow-up after intervention
Visual Analogue Scale
Time frame: Baseline
Visual Analogue Scale
Time frame: At the end of 8-week intervention
Visual Analogue Scale
Time frame: 1-month follow-up after intervention
Active Range of Motion Assessment
Time frame: Baseline
Active Range of Motion Assessment
Time frame: At the end of the 8-week intervention
Active Range of Motion Assessment
Time frame: 1-month follow-up after intervention
Muscle Strength
Time frame: At the end of the 8-week intervention
Muscle Strength
Time frame: 1-month follow-up after intervention
American Shoulder and Elbow Surgeons Shoulder Score
Time frame: Baseline
American Shoulder and Elbow Surgeons Shoulder Score
Time frame: At the end of the 8-week intervention
American Shoulder and Elbow Surgeons Shoulder Score
Time frame: 1-month follow-up after intervention
Short Form-12
Time frame: Baseline
Short Form-12
Time frame: At the end of the 8-week intervention
Short Form-12
Time frame: 1-month follow-up after intervention
Global Rating of Change
Time frame: At the end of the 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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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 Cross-education training and Standard 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?
The sponsor lists 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 May 2025. 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?
Results are not available in the source record.
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 20 May 2025.