Clinical trial NCT06194435: Teleexercise for Rotator Cuff Syndrome: A Comparison
Official title: Impact of Teleexercise and Remote Assessments in Rotator Cuff Syndrome: A Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Syndrome
Keywords: rotator cuff syndrome
telemedicine
teleexercise
asynchronous video
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-08
Enrollment: 81
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Levels
timeFrame: At the first day, the 15th day and the 6th month of the study.
measure: Functional Recovery
timeFrame: At the first day and the 15th day of the study.
measure: Exercise Adherence
timeFrame: From the first day till the 15th day of the study (15 days time frame).
Secondary outcomes:
measure: Patient Satisfaction with Likert Satisfaction Scale
timeFrame: From the first day till the 15th date of the study (15 days time frame).
measure: Evaluating Travel Distance and Time for Control Group In-Person Hospital Visits
timeFrame: Data will be collected on the first day of the study.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Selkin Yılmaz Muluk
Study officials:
affiliation: Antalya Ataturk Devlet Hastanesi
name: Selkin Yılmaz
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.