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

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring massive rotator cuff tear, deltoid, electromyographic biofeedback, rehabilitation, nonoperative management

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercise Group

EMG-BF Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
Deltoid Strength
Measurement of the strength of the deltoid muscle with a digital dynamometer.

Secondary Outcome Measures

Range of Motion (ROM)
Active ROM will evaluate with a universal goniometer.
Numeric Pain Rating Scale (NPRS)
Participants' level of pain will assess by numeric pain rating scale (NPRS).
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).

Full Information

First Posted
September 12, 2020
Last Updated
February 21, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04552925
Brief Title
Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears
Official Title
The Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 29, 2020 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
massive rotator cuff tear, deltoid, electromyographic biofeedback, rehabilitation, nonoperative management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
EMG-BF Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Exercises and rehabilitation for massive rotator cuff tears
Primary Outcome Measure Information:
Title
American shoulder and elbow (ASES) score
Description
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.
Time Frame
12 months
Title
Deltoid Strength
Description
Measurement of the strength of the deltoid muscle with a digital dynamometer.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Range of Motion (ROM)
Description
Active ROM will evaluate with a universal goniometer.
Time Frame
12 months
Title
Numeric Pain Rating Scale (NPRS)
Description
Participants' level of pain will assess by numeric pain rating scale (NPRS).
Time Frame
12 months
Title
Global rating of change scale (GRCS)
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Çelik, Professor
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University Cerrahpaşa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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