Clinical trial NCT05904249: Telerehabilitation in Individuals With Rotator Cuff Tear
Official title: Investigation of the Effectiveness of Telerehabilitation in Individuals With Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Physiotherapy and Rehabilitation
Shoulder Pain
Rotator Cuff Injuries
Keywords: Telerehabilitation
Remote Rehabilitations
Exercise Therapy
Telemedicine
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: One year
measure: Range of Motion Assessment
timeFrame: One year
measure: Muscle Activation Assessment
timeFrame: One year
measure: The Disabilities of the Arm, Shoulder and Hand Questionnaire
timeFrame: One year
measure: American Standardized Shoulder and Elbow Surgeon Assessment Form
timeFrame: One year
measure: Modified Constant-Murley
timeFrame: One year
Secondary outcomes:
measure: Short Form-12
timeFrame: One year
measure: Global Change Scale
timeFrame: One year
measure: Hospital Anxiety and Depression Scale
timeFrame: One year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa, Faculty of Medicine, Department of Orthopedics and Traumatology
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Nuri Aydin, Prof.Dr
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Mehmet Fatih Guven, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Bingol University
name: Emrah Zirek, Res.Assist.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Yildiz Analay Akbaba, Assoc.Prof.
role: STUDY_DIRECTOR
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