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

The Effectiveness of Exercises with Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04552925
Enrollment
36
Registered
2020-09-17
Start date
2020-09-22
Completion date
2021-12-30
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

Keywords

massive rotator cuff tear, deltoid, electromyographic biofeedback, rehabilitation, nonoperative management

Brief summary

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.

Interventions

OTHERRehabilitation

Exercises and rehabilitation for massive rotator cuff tears

Sponsors

Istanbul University
CollaboratorOTHER
Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
American shoulder and elbow (ASES) score12 monthsThe 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.
Deltoid Strength12 monthsMeasurement of the strength of the deltoid muscle with a digital dynamometer.

Secondary

MeasureTime frameDescription
Range of Motion (ROM)12 monthsActive ROM will evaluate with a universal goniometer.
Numeric Pain Rating Scale (NPRS)12 monthsParticipants' level of pain will assess by numeric pain rating scale (NPRS).
Global rating of change scale (GRCS)12 monthsThe 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026