Telerehabilitation in Individuals With Rotator Cuff Tear

NCT05904249 | Completed

• 1 other identifier: IstanbulU
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Physiotherapy and Rehabilitation; Shoulder Pain; Rotator Cuff Injuries

Keywords

Telerehabilitation; Remote Rehabilitations; Exercise Therapy; Telemedicine

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Short Form-12

  One year

• Global Change Scale

  One year

• Hospital Anxiety and Depression Scale

  One year

Study Arms (2)

Internet Based Synchronized Telerehabilitation Group (Group 1)

EXPERIMENTAL

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

Face-to-Face Rehabilitation Group (Group 2)

EXPERIMENTAL

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

Interventions

Internet Based Synchronized Telerehabilitation 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

Internet Based Synchronized Telerehabilitation Group (Group 1)

Face-to-Face Rehabilitation 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)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (42)

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MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuri Aydin, Prof.Dr

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Mehmet Fatih Guven, Assoc.Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Emrah Zirek, Res.Assist.

  Bingol University

  PRINCIPAL INVESTIGATOR

• Yildiz Analay Akbaba, Assoc.Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: June 15, 2023
• Study Start: February 7, 2022
• Primary Completion: March 10, 2023
• Study Completion: May 5, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)