Rotator Cuff Tears, Pain, Shoulder, Surgery
Conditions
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.
Interventions
OTHERCross-education training
The strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side.
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.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | Baseline | 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 | Baseline | 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 | At the end of the 8-week intervention | 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. |
| Constant-Murley Score | At the end of 8-week intervention | 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. |
| Short Form-12 | Baseline | 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 | At the end of the 8-week intervention | 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. |
| American Shoulder and Elbow Surgeons Shoulder Score | Baseline | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed