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

NCT ID: NCT04552925

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-12-30

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.

Detailed Description

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercise Group

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).

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

Exercises and rehabilitation for massive rotator cuff tears

EMG-BF Group

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).

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type OTHER

Exercises and rehabilitation for massive rotator cuff tears

Interventions

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Rehabilitation

Exercises and rehabilitation for massive rotator cuff tears

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Pelin Tiryaki

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya Çelik, Professor

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Locations

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Istanbul University Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Tiryaki P, Celik D, Bilsel K, Ersen A. Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study. Am J Phys Med Rehabil. 2023 May 1;102(5):419-426. doi: 10.1097/PHM.0000000000002111. Epub 2022 Sep 23.

Reference Type BACKGROUND
PMID: 36166658 (View on PubMed)

Other Identifiers

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2016/1507

Identifier Type: -

Identifier Source: org_study_id

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