Telerehabilitation in Individuals With Rotator Cuff Tear

NCT ID: NCT05904249

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2023-05-05

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tears Physiotherapy and Rehabilitation Shoulder Pain Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

Internet Based Synchronized Telerehabilitation

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Face-to-Face Rehabilitation

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Emrah Zirek

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuri Aydin, Prof.Dr

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Mehmet Fatih Guven, Assoc.Prof.

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Emrah Zirek, Res.Assist.

Role: PRINCIPAL_INVESTIGATOR

Bingol University

Yildiz Analay Akbaba, Assoc.Prof.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Other Identifiers

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IstanbulU

Identifier Type: -

Identifier Source: org_study_id

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