Teleexercise for Rotator Cuff Syndrome: A Comparison

Rotator Cuff Syndrome Clinical Trial

— TFRCSAC  

Official title:

Impact of Teleexercise and Remote Assessments in Rotator Cuff Syndrome: A Comparative Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194435
• Other study ID #: Antalya Ataturk State Hospital
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2023
• Est. completion date: June 24, 2024

Study information

• Verified date: June 2024
• Source: Antalya Training and Research Hospital
• Contact: Selkin Yilmaz Muluk
• Phone: +905321304062
• Email: selkin.yilmazmuluk[@]saglik.gov.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 involves a total of 102 voluntary participants.

Inclusion criteria for participants encompass the following: participants must be within the age range of 40 to 60, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: June 24, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Syndrome
• Syndrome

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Selkin Yilmaz Muluk	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and the last (15th) day of the study.
Primary	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 last (15th) day of the study.
Primary	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 last day of the study (15 days time frame).
Secondary	Patient Satisfaction with Likert Satisfaction Scale	Gathering feedback from participants on their satisfaction with the assigned treatment approach for shoulder pain using a Likert scale of satisfaction, where they rate their satisfaction level from 1 (Very Dissatisfied) to 5 (Very Satisfied).	From the first day till the last date of the study (15 days time frame).
Secondary	Evaluating Travel Distance and Time for Control Group In-Person Hospital Visits	Assessing Travel Distance and Time for Control Group Hospital Visits: Participants will provide details of their single-day round-trip travel from home to the hospital and back, including kilometers traveled and minutes spent. This data will be used to calculate the economic burden and time commitment associated with in-person hospital visits.	Data will be collected during three specific time points within the 15-day study period: on the first, the seventh, and the final day (15th day) when patients had their follow-up appointments with doctor. (on 3 time points in 15 days of time frame)

External Links

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