Back to resultsCross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
Primary Purpose
Rotator Cuff Tears, Pain, Shoulder, Surgery
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cross-education training
Standard exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
Eligibility Criteria
Inclusion Criteria:
Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish
Exclusion Criteria:
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cross-education group
Standard exercise group
Arm Description
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.
Each subject in the standard exercise group will receive a treatment protocol consisting of standard exercise program applied after arthroscopic rotator cuff repair.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05266339
First Posted
February 28, 2022
Last Updated
August 9, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05266339
Brief Title
Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
Official Title
Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Pain, Shoulder, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cross-education group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard exercise group
Arm Type
Active Comparator
Arm Description
Each subject in the standard exercise group will receive a treatment protocol consisting of standard exercise program applied after arthroscopic rotator cuff repair.
Intervention Type
Other
Intervention Name(s)
Cross-education training
Intervention Description
The strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side.
Intervention Type
Other
Intervention Name(s)
Standard exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Constant-Murley Score
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Constant-Murley Score
Description
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.
Time Frame
At the end of 8-week intervention
Title
Constant-Murley Score
Description
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.
Time Frame
1-month follow-up after intervention
Title
Visual Analogue Scale
Description
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.
Time Frame
Baseline
Title
Visual Analogue Scale
Description
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.
Time Frame
At the end of 8-week intervention
Title
Visual Analogue Scale
Description
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.
Time Frame
1-month follow-up after intervention
Title
Active Range of Motion Assessment
Description
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.
Time Frame
Baseline
Title
Active Range of Motion Assessment
Description
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.
Time Frame
At the end of the 8-week intervention
Title
Active Range of Motion Assessment
Description
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.
Time Frame
1-month follow-up after intervention
Title
Muscle Strength
Description
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.
Time Frame
At the end of the 8-week intervention
Title
Muscle Strength
Description
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.
Time Frame
1-month follow-up after intervention
Title
American Shoulder and Elbow Surgeons Shoulder Score
Description
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.
Time Frame
Baseline
Title
American Shoulder and Elbow Surgeons Shoulder Score
Description
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.
Time Frame
At the end of the 8-week intervention
Title
American Shoulder and Elbow Surgeons Shoulder Score
Description
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.
Time Frame
1-month follow-up after intervention
Title
Short Form-12
Description
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.
Time Frame
Baseline
Title
Short Form-12
Description
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.
Time Frame
At the end of the 8-week intervention
Title
Short Form-12
Description
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.
Time Frame
1-month follow-up after intervention
Title
Global Rating of Change
Description
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.
Time Frame
At the end of the 8-week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tansu Birinci, PT, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Bakırkoy
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
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