Telerehabilitation in Individuals With Rotator Cuff Tear

June 6, 2023 updated by: Emrah Zirek, Istanbul University - Cerrahpasa (IUC)

Investigation of the Effectiveness of Telerehabilitation in Individuals With Rotator Cuff Tear

The majority of patients presenting with shoulder pain are those with rotator cuff problems. Although telerehabilitation is a promising field in many areas, there is still limited high-quality research with strong evidence of its effectiveness for musculoskeletal problems. In this study, online rehabilitation and face-to-face rehabilitation will be compared in people with partial rotator cuff tears.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of shoulder pain increases with age and is mostly associated with inadequate treatment of symptoms. A large part of the patients who apply to the clinic with the complaint of shoulder pain are individuals with rotator cuff problems. Partial rotator cuff (RM) tear is defined as tears that can be seen on the superior, inferior, or both sides of the cuff. It is stated that the most critical risk factors for RM tear are age, dominant arm, and trauma. The degenerative process is generally considered normal in age-related tears and is seen in 20% of individuals over the age of 65.

The Coronavirus disease (COVID-19), is still the most important global concern. People with chronic diseases have been known to delay getting healthcare services due to fear of the risk of infection following the COVID-19 pandemic. This could lead to increased morbidity and mortality due to delay and disruption in access to treatment applications needed for patient populations other than COVID-19. At this stage, one of the applications that can be effective for disturbed patient healing processes is the Telerehabilitation application, which has proven its effectiveness in previous epidemics (EBOLA, SARS, etc.), when patients are treated remotely after and after treatment. Especially during the COVID-19 pandemic, there has been an increase in the need for Internet-based remote treatment approaches, as it allows both patients and physiotherapists to advance the treatment process without the risk of infection. In the next decade, telerehabilitation options are expected to diversify and become widespread in assessing and treating many diseases with emerging technologies.

Studies have shown that despite the growing number of applications of telerehabilitation worldwide, evidence for clinical effectiveness is still limited. In addition, the effectiveness of telerehabilitation for musculoskeletal problems has not been fully demonstrated due to the lack of a specific standard for telerehabilitation and the variability of the approaches used. In conclusion, although telerehabilitation is a promising field in many areas, there is still a limited amount of good-quality research with strong evidence.

Therefore, this study aimed to compare the effects of internet-based telerehabilitation and face-to-face rehabilitation practices on pain, range of motion, functionality, and quality of life in patients with partial rotator cuff injury.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University- Cerrahpasa, Faculty of Medicine, Department of Orthopedics and Traumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presence of bursal facial tear 1 cm below the tear degree; presence of complaints of shoulder pain lasting for a minimum of 1 and a maximum of 6 months; having been diagnosed with partial rotator cuff tear by an orthopedist who is an expert in the field; no shoulder instability; inadequate response to non-operative treatment (corticosteroid injection, anti-inflammatory drugs, rest and physiotherapy and rehabilitation); not using corticosteroid drug; being between the ages of 18-60; to have sufficient knowledge, skills and technological tools to access the Tele-Rehabilitation application.

Exclusion Criteria:

  • Presence of malignancy affecting the shoulder region; disc herniations that may cause shoulder pain; individuals with inflammatory joint disease; osteoarthritis of the humeral head; history of surgery affecting the shoulder; inability of the patient to cooperate; systemic problems that cannot be controlled with medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet Based Synchronized Telerehabilitation Group (Group 1)
The treatments of the participants who meet the inclusion criteria in the study will be conducted remotely via instant video communication. The Specialist Physiotherapist will apply the necessary exercises, verbal guidance or repetition of the movements shown, according to the patient's condition, synchronized via instant video and audio calls (Whatsapp or Zoom).
Other: Internet Based Synchronized Telerehabilitation

Week 1

  • Posterior capsule stretching
  • Passive range of motion
  • Wand exercises in supine position
  • Scapular adduction exercise
  • Ball rolling on the table (<90°)
  • Coldpack (15min)

Week 2

  • Wand exercises while standing.
  • Ball roll on wall (>90°)
  • Ball roll on the table (90°)
  • Weightless External Rotation exercises
  • Functional PNF movements

Week 3

  • Resistive scapulothoracic strengthening
  • Ball scrolling on the table (resistive)

Week 4

  • Single handed ball roll on the table (>90°)
  • External rotation exercise with 0.5-1kg weight in side lying
  • Strengthening exercises, shoulder in 90° scapulation for 10s

Week 5

  • External rotation with 0.5-1 kg weight in side lying
  • Strengthening exercises by keeping the shoulder in 90° scapulation for 10s

Week 6-8

  • Dynamic hugs and push up plus
  • Ball throwing and catching
Experimental: Face-to-Face Rehabilitation Group (Group 2)
The treatments of the participants that meet the inclusion criteria of the study will be administered by Specialist Physiotherapist. The progress of the patients will be regularly followed up on a weekly basis, and treatments will be applied in accordance with the program in rehabilitation.
Other: Face-to-Face Rehabilitation

Week 1

  • Posterior capsule stretching
  • Passive range of motion
  • Wand exercises in supine position
  • Scapular adduction exercise
  • Ball rolling on the table (<90°)
  • Coldpack (15min)

Week 2

  • Wand exercises while standing.
  • Ball roll on wall (>90°)
  • Ball roll on the table (90°)
  • Weightless External Rotation exercises
  • Functional PNF movements

Week 3

  • Resistive scapulothoracic strengthening
  • Ball scrolling on the table (resistive)

Week 4

  • Single handed ball roll on the table (>90°)
  • External rotation exercise with 0.5-1kg weight in side lying
  • Strengthening exercises, shoulder in 90° scapulation for 10s

Week 5

  • External rotation with 0.5-1 kg weight in side lying
  • Strengthening exercises by keeping the shoulder in 90° scapulation for 10s

Week 6-8

  • Dynamic hugs and push up plus
  • Ball throwing and catching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: One year
Patients' pain levels at rest, during activity, and at night will be assessed using a Visual Analog Scale (VAS). The score is determined by measuring the distance (mm) on a 10 cm line between the "no pain" anchor and the patient's mark, providing a score range of 0 to 100. A higher score indicates greater pain intensity.
One year
Range of Motion Assessment
Time Frame: One year
The range of motion values of the participants will be recorded using the universal goniometer, which is an objective tool used in clinical range of motion measurement.The flexion, scapular abduction, internal and external rotation values of the shoulder joint will be measured in the supine position with a universal goniometer in accordance with the procedure in the literature.
One year
Muscle Activation Assessment
Time Frame: One year
Delsys Biometrics Datalite WS450, a surface EMG system, will be used to evaluate the function of the shoulder muscles. Previous studies and the website of the SENIAM project of the European Union Biomedical Health and Research Program (http://www.seniam.org/) will be accepted as reference.
One year
The Disabilities of the Arm, Shoulder and Hand Questionnaire
Time Frame: One year
Hand, Shoulder and Hand Disability Questionaire will be used to assess the functional state of the participants. The possible score ranges from 0 to 100 points. 0 points represent full unrestricted upper limb function and 100 points represent the maximum possible functional impairment.
One year
American Standardized Shoulder and Elbow Surgeon Assessment Form
Time Frame: One year
The ASES section on patient self-reports is a condition-specific scale, i.e. it is for a specific condition that is intended to measure functional limitation and shoulder pain. The total pain score and the functional score are equally weighted (50 points each) and are combined to obtain a total score out of a possible 100 points.
One year
Modified Constant-Murley
Time Frame: One year
The Modified Constant-Murley Scale is widely used to assess disability associated with shoulder injuries, but has been criticized for its use of inaccurate terminology and the lack of a standardized methodology. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. The higher the score, the higher the quality of the function.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form-12
Time Frame: One year
Short Form-12 will be used to assess quality of life related to physical and mental health. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). SF-12 PCS mean scores ranged between 48.3 and 49.2, and SF-12 MCS mean scores ranged between 48.0 and 49.6.
One year
Global Change Scale
Time Frame: One year
The satisfaction levels of the participants will be assessed using the Global Change Scale. Subjects are asked to rate their post-treatment status on a 5-point scale (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better). A high score is considered a sign of high satisfaction.
One year
Hospital Anxiety and Depression Scale
Time Frame: One year
Participants' levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21); 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe).
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Nuri Aydin, Prof.Dr, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Mehmet Fatih Guven, Assoc.Prof., Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Emrah Zirek, Res.Assist., Bingol University
  • Study Director: Yildiz Analay Akbaba, Assoc.Prof., Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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