Telerehabilitation in Individuals With Rotator Cuff Tear

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904249
• Other study ID #: IstanbulU
• Status: Completed
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: June 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 5, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa, Faculty of Medicine, Department of Orthopedics and Traumatology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	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
Primary	Range of Motion Assessment	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
Primary	Muscle Activation Assessment	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
Primary	The Disabilities of the Arm, Shoulder and Hand Questionnaire	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
Primary	American Standardized Shoulder and Elbow Surgeon Assessment Form	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
Primary	Modified Constant-Murley	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	Short Form-12	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
Secondary	Global Change Scale	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
Secondary	Hospital Anxiety and Depression Scale	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