Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial

Surgery Clinical Trial

Official title:

Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05266339
• Other study ID #: 109
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: August 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 15, 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Shoulder
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain
• Surgery

Intervention

Other:
• Cross-education training
The strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side.
• Standard exercise program
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	At the end of 8-week intervention
Secondary	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.	1-month follow-up after intervention
Secondary	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.	Baseline
Secondary	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.	At the end of 8-week intervention
Secondary	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.	1-month follow-up after intervention
Secondary	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.	Baseline
Secondary	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.	At the end of the 8-week intervention
Secondary	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.	1-month follow-up after intervention
Secondary	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.	At the end of the 8-week intervention
Secondary	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.	1-month follow-up after intervention
Secondary	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.	Baseline
Secondary	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.	At the end of the 8-week intervention
Secondary	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.	1-month follow-up after intervention
Secondary	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.	Baseline
Secondary	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.	At the end of the 8-week intervention
Secondary	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.	1-month follow-up after intervention
Secondary	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.	At the end of the 8-week intervention