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Completed

NCT Number: NCT04552925

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

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpaşa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

Exercises and rehabilitation for massive rotator cuff tears

Primary outcomes

  1. American shoulder and elbow (ASES) score

    Time frame: 12 months

    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.

  2. Deltoid Strength

    Time frame: 12 months

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

Secondary outcomes

  1. Range of Motion (ROM)

    Time frame: 12 months

    Active ROM will evaluate with a universal goniometer.

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: 12 months

    Participants' level of pain will assess by numeric pain rating scale (NPRS).

  3. Global rating of change scale (GRCS)

    Time frame: 12 months

    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).

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Istanbul University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 17, 2020
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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