Teleexercise for Rotator Cuff Syndrome: A Comparison

NCT06194435 | Completed

• 1 other identifier: Antalya Ataturk State Hospital
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator Cuff Syndrome (RCS) often lead to shoulder pain and reduced function, creating a demand for alternative treatments. This study examines the effectiveness of remote assessments and tele-exercise compared to traditional in-person methods for treating these injuries. The telemedicine group will receive remote consultations and asynchronous exercise videos, while the control group will have face-to-face meetings and comprehensive information. Follow-up assessments will track exercise compliance for both groups. Additionally, a questionnaire will assess functionality, and pain levels will be evaluated using a pain scale, providing a comprehensive evaluation of treatment outcomes.

Conditions

Rotator Cuff Syndrome

Keywords

rotator cuff syndrome; telemedicine; teleexercise; asynchronous video

Outcome Measures

Primary Outcomes (3)

• Pain Levels

  Assessments of pain intensity using the numeric-Visual Analog Scale (VAS). The numeric-VAS typically ranges from 0 to 10, with 0 representing no pain or symptom and 10 representing the worst imaginable pain or symptom. The highest score on the VAS is 10, indicating the most severe pain or symptom.

  At the first day, the 15th day and the 6th month of the study.

• Functional Recovery

  Evaluation of upper extremity function using the Quick-Disabilities of Arm, Shoulder, Hand (DASH) questionnaire. The Quick-DASH score can range from 0 to 100, with higher scores indicating more severe disability or symptoms. A score of 0 would mean no disability or symptoms, while a score of 100 would suggest the most severe disability or symptoms. Generally, a lower Quick-DASH score represents better functioning and less disability.

  At the first day and the 15th day of the study.

• Exercise Adherence

  Monitoring and recording participants' adherence to the prescribed home exercise program through exercise diaries. This would involve tracking the frequency and consistency of exercise performance.

  From the first day till the 15th day of the study (15 days time frame).

Secondary Outcomes (2)

• Patient Satisfaction with Likert Satisfaction Scale

  From the first day till the 15th date of the study (15 days time frame).

• Evaluating Travel Distance and Time for Control Group In-Person Hospital Visits

  Data will be collected on the first day of the study.

Study Arms (2)

Telemedicine Group: Remote Assessments and Asynchronous Exercise Guidance

EXPERIMENTAL

For the Telemedicine Group, the study initiates with a video call from the physician on day one via FaceTime or WhatsApp. During these calls, patients will receive guidance and complete Quick-DASH questionnaire and numeric-VAS scale. On the same day, they will also receive an exercise video and an exercise diary via WhatsApp. Follow-up video calls on the 7th day will serve as reminders and allow patients to ask questions. The final video call, scheduled for the 15th day, will involve completing the same questionnaire and scale. After this last remote interaction, patients will send photos of their completed exercise logs to the physician via WhatsApp for adherence tracking.

Other: Remote Monitoring of Participant Progress and Well-being via Video Calls

Control Group: In-Person Assessments in Clinic and Exercise Brochure

ACTIVE COMPARATOR

For the Control Group, the study begins with an in-person visit to the physician on day one. During this visit, patients will receive guidance, complete Quick-DASH questionnaire and numeric-VAS scale, and be provided with an exercise brochure. Additionally, patients will receive an exercise diary on the same day to record their exercise sessions. Follow-up visits to the physician's office at the hospital on the 7th day will serve as reminders and opportunities for patients to ask questions. On the 15th day, patients will revisit the hospital to complete the same questionnaire and scale. We will also assess the time spent and economic burden associated with hospital visits. Furthermore, exercise diaries will be collected for adherence tracking and progress evaluation.

Other: Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being

Interventions

Remote Monitoring of Participant Progress and Well-being via Video Calls OTHER

Participants with Rotator Cuff Syndrome undergo remote evaluations via video calls with a physician. On the same day, they receive an asynchronous exercise brochure containing instructions for performing home exercises three times a day. They are also provided with an exercise diary to track their daily exercise sessions. Follow-up assessments and discussions about their condition take place remotely on video calls with the physician on the 7th and 15th days. During the final video call on the 15th day, participants are asked to submit their exercise diaries via WhatsApp for assessment of exercise adherence.

Also known as: Delivery of Asynchronous Home Exercise Video Through WhatsApp, Monitoring Exercise Adherence Using Exercise Diaries, Evaluating Shoulder Function and Pain Using Questionnaire and Pain Scale After Home Exercise Program

Telemedicine Group: Remote Assessments and Asynchronous Exercise Guidance

Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being OTHER

Participants with Rotator Cuff Syndrome undergo in-clinic evaluations by a physician, during which they receive an exercise brochure with instructions for performing home exercises three times a day. They are also given an exercise diary to track their daily exercise sessions. On the 7th and 15th days, participants return for follow-up assessments and discussions about their condition. During the final clinic visit, participants are requested to submit their exercise diaries for assessment of exercise adherence.

Also known as: Hand-Delivery of Home Exercise Brochure, Monitoring Exercise Adherence Using Exercise Diaries, Evaluating Shoulder Function and Pain Using Questionnaire and Pain Scale After Home Exercise Program

Control Group: In-Person Assessments in Clinic and Exercise Brochure

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of rotator cuff tendinosis, tendinitis, impingement, or partial muscle rupture confirmed by shoulder MRI,
• Not benefiting from conservative methods such as activity restriction, ice application and analgesics, being referred to physical therapy sessions,
• Having single-sided shoulder problem, possessing the ability to understand and perform prescribed exercises,
• Having the cognitive and psychological capacity to read and interpret brochures, being familiar to smartphones for accessing digital exercise materials,
• Having internet access.

You may not qualify if:

• Cognitive impairment,
• Bilateral rotator cuff syndrome,
• Total rupture of rotator cuff muscle,
• Previous fractures or surgeries on the same shoulder,
• Shoulder instability,
• Visual impairments,
• Extremity amputations,
• Advanced cancer and complicated diabetes,
• Recent injections to the same shoulder within the last 6 months,
• Having received physical therapy or home exercise advice within the last 6 months,
• Lacking personal smartphones or internet access,
• Undergoing cancer treatment.

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Selkin Yılmaz Muluk

Antalya, 07040, Turkey (Türkiye)

Location

Related Publications (2)

• Harms S, Kobusingye O. Factors that influence the use of rehabilitation services in an urban Ugandan hospital. Int J Rehabil Res. 2003 Mar;26(1):73-7. doi: 10.1097/00004356-200303000-00012.

  PMID: 12601273 BACKGROUND

• Amorese AJ, Ryan AS. Home-Based Tele-Exercise in Musculoskeletal Conditions and Chronic Disease: A Literature Review. Front Rehabil Sci. 2022 Feb 24;3:811465. doi: 10.3389/fresc.2022.811465. eCollection 2022.

  PMID: 36188988 BACKGROUND

Related Links

• 'Rotator Cuff and Shoulder Conditioning Program' of American Academy of Orthopaedic Surgeons.

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Selkin Yılmaz

  Antalya Ataturk Devlet Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person conducting the statistical analysis will be unaware of group identities, she will perform the data analysis without knowledge of which group received which treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Physical Therapy and Rehabilitation specialist

Model Details: Study Design: This study utilizes a randomized controlled parallel-design approach to evaluate the effectiveness of telemedicine methods in treating RCS compared to traditional in-person methods. Participants: The study will include 76 participants aged 40 to 60 years diagnosed with RCS, confirmed through shoulder MRI, and unresponsive to conservative treatments. They are randomly assigned to two groups. Intervention Group/Telemedicine Group: Remote assessments, video exercise program, and virtual follow-ups. Control Group: In-person assessments, exercise program, and follow-ups. Data Collection: Comprehensive documentation of clinical diagnoses and demographics, informed consent, and outcome measures (Quick-DASH and Numeric-VAS) are collected. Outcome Measures: The study assesses pain levels, functional recovery, and overall treatment outcomes. Analysis: Statistical analysis is conducted to compare treatment effectiveness between the two groups.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 8, 2024
• Study Start: November 24, 2023
• Primary Completion: June 19, 2024
• Study Completion: June 24, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months after study completion
• Access Criteria: Access to the individual participant data will be granted to qualified researchers, institutions, or individuals who submit a formal request.

Locations

TU (1)