Rotator Cuff Tears
Conditions
Keywords
Shoulder, Biofeedback, Kinematics
Brief summary
The present study addresses the issue about post-surgical recovery process, for patients arthroscopically treated for rotator-cuff tear. The aim of the research is to test the effectiveness of a new rehabilitation protocol that includes kinematic biofeedback with the motion analysis system ISEO.
Detailed description
The research includes at least 62 patients arthroscopically treated for the rotator cuff tear. For this purpose, two groups of patients of equal size are identified. The attribution of each patient to one of the two groups is random. The standard rehabilitation protocol is applied to the Control group (Group A), whereas the standard rehabilitation protocol integrated by proprioception exercises (physical therapist assisted) performed with ISEO is applied to the Experimental group (Group B). The primary objective is to verify if the ISEO system, used as a biofeedback tool, improves shoulder functionality and activity of patients arthroscopically treated for rotator cuff tear, both in the short (90 days from surgery) and in the medium term (6-12 months from surgery). All patients are longitudinally evaluated from the pre-surgery to a 6/12 months follow-up. Each evaluation includes both a clinical and an instrumented assessment of shoulder kinematics. The primary outcome tested is the Scapula-Weighted Constant-Murley Score, which represents a reformulation of the Constant-Murley Score, which is modified based on the quality of the scapular movement measured with ISEO.
Interventions
DEVICEKinematic biofeedback with ISEO motion analysis system
Exercises are performed with the help of the ISEO motion analysis system, that provides a real-time biofeedback of shoulder kinematics. All exercises are administered by the Physical Therapist.
Sponsors
AUSL Romagna Rimini
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study considers participants divided in two groups: the control group and the experimental group.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients with rotator cuff injuries; * asymptomatic contralateral shoulder, that can be considered as a reference for the differential evaluation; * indication for arthroscopy; * employees; * rehabilitation executed at AUSL-Romagna.
Exclusion criteria
* irreparable injuries of the rotator cuff; * contralateral painful shoulder; * patients being treated for cancer in the last 6 months; * patients with concomitant neurological pathologies; * patients with spinal cord injuries; * patients with cuff lesions with infectious processes; * patients with severe scoliosis; * patients with recurrent lesions of the cuff; * patients with occupational diseases or work-related accidents; * patients for whom the return to work cannot be reliably established.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5A | 6 months after surgery | The SW-CMS is a modified version of the CMS, based on the quality of the movement of the scapula: the score referred to humerus elevation is weighted based on scapula movement. The Score varies between 0 (worse) and 100 (best) points. |
| The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5B | 12 months after surgery | The SW-CMS is a modified version of the CMS, based on the quality of the movement of the scapula: the score referred to humerus elevation is weighted based on scapula movement. The Score varies between 0 (worse) and 100 (best) points. |
| The Scapula-Weighted Constant-Murley Score (SW-CMS) at T3 | 90 days after surgery | The SW-CMS is a modified version of the CMS, based on the quality of the movement of the scapula: the score referred to humerus elevation is weighted based on scapula movement. The Score varies between 0 (worse) and 100 (best) points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | The DASH is a very popular questionnaire that quantifies the level of disability of a patient with upper limb disease. The questionnaire is a self-administered by the patient. The DASH varies between 0 (best) and 100 (worse) points. |
| EuroQol five-dimension scale (EQ-5D) | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | The EQ-5D is a standard questionnaire for the measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The EQ-5D varies between 0 (worse) and 100 (best) points. |
| Pectoralis Minor length | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | Pectoralis Minor length in mm |
| Body Mass Index (BMI) | Before surgery | The BMI is measure in kg/m\^2 |
| Cervical pain: Presence of cervical pain YES or NOT. If YES, why | Before surgery | It is measured by the Doctor as follows: Presence of cervical pain YES or NOT. If YES, why. |
| Superficial Electromyography (sEMG) | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | The sEMG is the electrical activity of shoulder superficial muscles. Muscles acquired are: Deltoid (anterior and posterior), Trapezius (upper, medium and lower), Serratus Anterior, Pectoralis Major and Latissimus Dorsi. |
| Constant-Murley Score (CMS) | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | The CMS is a standard questionnaire for the evaluation of patients with shoulder diseases, one of the most widespread in Europe. The Score varies between 0 (worse) and 100 (best) points. |
| American Shoulder and Elbow Score (ASES) | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | The ASES is a very popular questionnaire (in particular in the USA), partly completed from the patient and partly completed from the doctor. The part dedicated to the patient provides for an assessment of pain, instability and daily life activities. The part filled in by the doctor includes 4 items on tenderness. The ASES varies between 0 (worse) and 100 (best) points. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of job-change | T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | Percentage of patients that had to change their job |
| Degree of satisfaction of the patient: score | T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery). | Evaluation of the satisfaction of the patient during the rehabilitation period. The score varies from 0 (totally unsatisfied) and 10 (totally satisfied). |
Countries
Italy
Outcome results
None listed