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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552925
• Other study ID #: 2016/1507
• Status: Completed
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 30, 2021
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• Rehabilitation
Exercises and rehabilitation for massive rotator cuff tears

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Deltoid Strength	Measurement of the strength of the deltoid muscle with a digital dynamometer.	12 months
Secondary	Range of Motion (ROM)	Active ROM will evaluate with a universal goniometer.	12 months
Secondary	Numeric Pain Rating Scale (NPRS)	Participants' level of pain will assess by numeric pain rating scale (NPRS).	12 months
Secondary	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