Teleexercise for Rotator Cuff Syndrome: A Comparison

NCT ID: NCT06194435

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2024-06-24

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.

Detailed Description

This study employs a randomized controlled clinical trial with a parallel design conducted at a hospital-based Physical Therapy and Rehabilitation Clinic. The study is planned to involve 76 voluntary participants.

Inclusion criteria for participants encompass the following: participants must be within the age range of 30 to 65, diagnosed with conditions such as rotator cuff tendinosis, tendinitis, impingement, or partial rupture, confirmed through shoulder MR imaging, have not experienced improvement through conservative methods (e.g., activity restriction, ice application, and analgesics), and must have been referred for physical therapy sessions.

Participants will be randomly assigned to two groups, with efforts to maintain balance in terms of age and gender distribution. Data collection methods include detailed documentation of participants' clinical diagnoses and demographic information (e.g., age, gender, education level, occupation, dominance of the affected side, and whether the occupation involves physical labor or heavy lifting).

Before the study commences, all participants will receive comprehensive explanations of the study's objectives, provide informed consent by signing consent forms, and share their contact information for communication purposes. Participants will be informed of their rights to discontinue treatment at any point and to reach out to the researcher with questions or concerns during the study.

Participants in the Exercise Group will have face-to-face assessments at the clinic on the first day. This includes completing the Quick- Disabilities of the Arm, Shoulder and Hand (Quick- DASH) questionnaire and the Numeric Visual Analog Scale (VAS) for pain assessment. They will receive information about their condition, a brochure containing a home exercise program, and an exercise diary to record exercise details. Follow-up assessments will occur on the 7th and 15th days at the clinic.

Participants in the Telemedicine Group will have a different approach. On the first day of the study, they will have video calls through FaceTime or WhatsApp. The Quick-DASH questionnaire and Numeric VAS scale will be administered and they will receive information about their condition. Subsequently, a pre-recorded video comprising the home exercise program, along with an exercise diary to record exercise details, will be sent to them via WhatsApp. Follow-up assessments will occur on the 7th and 15th days through video calls. Both groups will receive regular follow-up phone calls to collect their VAS scores at the 6th-month mark.

The Quick-DASH questionnaire assesses upper extremity function, including functionality, pain, symptoms, and quality of life. It consists of 11 questions, each scored on a scale. The Numeric VAS pain scale measures pain intensity on a scale of 0 to 10.

The exercise brochure includes exercise descriptions and visual demonstrations aimed at improving joint range of motion, adapted from programs provided by the American Academy of Orthopaedic Surgeons.

The exercise diary provided to participants consists of a table with three columns for each day, spanning 15 days in total. Each day is divided into three time slots: morning, noon, and evening. Participants will be instructed to mark the relevant box when they complete the exercises at the specified times, and if they do not perform the exercises during that particular time slot on a given day, they should leave the box empty.

This methodology aims to assess the impact of telemedicine methods on the treatment outcomes of RCS patients compared to traditional methods, as well as to improve patients' access to treatment and enhance the efficiency of healthcare resources.

Conditions

Rotator Cuff Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telemedicine Group: Remote Assessments and Asynchronous Exercise Guidance

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

Other Intervention Names

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; 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

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Selkin Yılmaz Muluk

MD, Physical Therapy and Rehabilitation specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selkin Yılmaz

Role: PRINCIPAL_INVESTIGATOR

Antalya Ataturk Devlet Hastanesi

Locations

Selkin Yılmaz Muluk

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 12601273 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36188988 (View on PubMed)

Related Links

https://orthoinfo.aaos.org/globalassets/pdfs/2017-rehab_shoulder.pdf

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

Other Identifiers

Antalya Ataturk State Hospital

Identifier Type: -

Identifier Source: org_study_id