Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears

Study Overview
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Brief Summary
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There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. The aim of conservative treatment is to make the patient functionally independent and to reduce pain. In recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive RC tears. However, in recent biomechanical studies, it has been reported that the RC and the deltoid, which remain intact in massive RC tears, can function well together. The hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with EMG biofeedback, will give more positive results in terms of range of motion (ROM), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (EMG-BF) device which was added to deltoid focused conservative treatment program in massive RC tears.

Official Title
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The Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral, non-traumatic massive rotator cuff tears according to Deorio and Cofield classification Age older than 50 years and attend 1-year follow-up assessment Exclusion Criteria: Patients with symptomatic lesions in the contralateral shoulder Cuff tear arthropathy Glenohumeral osteoarthritis Pseudoparalytic shoulder Grade 3-4 fatty degeneration according to Goutallier classification History of involved shoulder surgery Major systemic conditions that disallowing exercise

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Group<br>Exercise group will receive ROM exercises, stretching and anterior deltoid re-education exercises described by Levy et al. Subjects will treated at the clinic three times per week for 6 weeks (18 sessions). | Other: Rehabilitation<br>* Exercises and rehabilitation for massive rotator cuff tears<br>|
| Experimental: EMG-BF Group<br>EMG-BF group will receive the same exercises as with the other group, but deltoid re-education exercises were performed under the guidance of EMG-BF device. All subjects will treated at the clinic three times per week for 6 weeks (18 sessions). | Other: Rehabilitation<br>* Exercises and rehabilitation for massive rotator cuff tears<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American shoulder and elbow (ASES) score | The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) is a standard shoulder assessment form, which is comprised of objective and subjective sections and prepared by shoulder and elbow surgeons. | 12 months | 
| Deltoid Strength | Measurement of the strength of the deltoid muscle with a digital dynamometer. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) | Active ROM will evaluate with a universal goniometer. | 12 months | 
| Numeric Pain Rating Scale (NPRS) | Participants' level of pain will assess by numeric pain rating scale (NPRS). | 12 months | 
| Global rating of change scale (GRCS) | The global rating of change scale (GRCS) which is five-point Likert scale will be use to evaluate the difference between the participants' health status from their perspective. It is ranging from -2 (very much worse), through 0 (unchanged) to +2 (much better). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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massive rotator cuff tear, deltoid, electromyographic biofeedback, rehabilitation, nonoperative management