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

NCT04552925 | Completed

• 1 other identifier: 2016/1507
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Range of Motion (ROM)

  12 months

• Numeric Pain Rating Scale (NPRS)

  12 months

• Global rating of change scale (GRCS)

  12 months

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

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

EMG-BF Group

EXPERIMENTAL

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

Interventions

Rehabilitation OTHER

Exercises and rehabilitation for massive rotator cuff tears

EMG-BF Group; Exercise Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Istanbul University: collaborator

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36166658 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Derya Çelik, Professor

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 17, 2020
• Study Start: September 22, 2020
• Primary Completion: December 29, 2020
• Study Completion: December 30, 2021
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)