Telerehabilitation in Individuals With Rotator Cuff Tear

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Completed

CT.gov ID

NCT05904249

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears Physiotherapy and Rehabilitation Shoulder Pain Rotator Cuff Injuries	Other: Internet Based Synchronized Telerehabilitation Other: Face-to-Face Rehabilitation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Study groups will be randomized by Researcher 3 using the Research Randomizer (https://www.randomizer.org). Researcher 1 will be blinded when selecting a treatment group. Rehabilitation practices for both groups will be conducted by the Researcher 1 and outcome evaluation will be conducted by the Researcher 2. The Researcher 2 will not know which group the data of the patient he/she is evaluating belongs to.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 7, 2022

Actual Primary Completion Date :

Mar 10, 2023

Actual Study Completion Date :

May 5, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual Analog Scale [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.
Range of Motion Assessment [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.
Muscle Activation Assessment [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.
The Disabilities of the Arm, Shoulder and Hand Questionnaire [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.
American Standardized Shoulder and Elbow Surgeon Assessment Form [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.
Modified Constant-Murley [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.

Secondary Outcome Measures

Short Form-12 [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.
Global Change Scale [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.
Hospital Anxiety and Depression Scale [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University- Cerrahpasa, Faculty of Medicine, Department of Orthopedics and Traumatology	Istanbul		Turkey

Sponsors and Collaborators

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)