Rotator Cuff Injuries, Rotator Cuff Tear, Telemedecine
Conditions
Keywords
Rotator Cuff Tears, Rotator Cuff Injuries, Telerehabilitation, Mobile Application, Digital Health, Arthroscopic Rotator Cuff Repair
Brief summary
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
Detailed description
Shoulder pain is the third most common medical condition seen in primary care settings, with 65-70% of patients experiencing rotator cuff injuries. Therefore, rotator cuff injuries significantly impact patients' mobility and place a considerable burden on the healthcare system and employers. The majority of patients are treated conservatively; however, approximately 40% of patients with rotator cuff tears, in which the primary injury is a tear of the supraspinatus and infraspinatus tendons, experience persistent pain and require surgical intervention. Effective rehabilitation programs can address disability and functional impairments in patients, such as joint range of motion, muscle strength, and persistent pain. However, not all patients who have undergone rotator cuff surgery have full access to in-person rehabilitation programs due to geographical, financial, and awareness barriers, or other objective factors such as epidemics. Furthermore, many patients lack the skills and knowledge to perform guided exercises at home, or receive inadequate guidance. In this context, tele-rehabilitation is considered a potential solution to mitigate the drawbacks of in-person and self-training methods. This study was designed to address gaps in practical implementation by evaluating whether the addition of a culturally adapted smartphone-based telerehabilitation application to standard postoperative physiotherapy could improve clinical outcomes compared to using standard physiotherapy alone. The primary objective was to determine the effectiveness of combined telerehabilitation intervention on shoulder function, as measured by changes in Constant-Murley and Quick DASH scores 24 weeks after arthroscopic repair of rotator cuff tendon injuries. Secondary objectives include assessing the impact of the intervention on active range of motion, isotonic shoulder strength, pain intensity, specific functional capacity of the patient, psychological factors (movement anxiety and rehabilitation confidence), treatment adherence, health-related quality of life, return to work status, direct non-medical costs, and caregiver time burden. The study will also assess safety through the rate of rotator cuff re-tear after 24 weeks and investigate factors related to treatment response. The study employs a comprehensive biopsychosocial assessment. Beyond physical recovery, we evaluate the interplay between psychological barriers (kinesiophobia via TSK-11), psychological assets (self-efficacy via SER), and resulting clinical behavior (adherence via EARS) to provide a holistic view of the patient's rehabilitation journey. This is a randomized, controlled, single-center clinical trial conducted at Viet Duc Friendship Hospital in Hanoi, Vietnam. A total of 102 patients eligible for arthroscopic rotator cuff repair are expected to be recruited and randomized in a 1:1 ratio into either the intervention or control group using a computer-generated block randomization. During the first 6 weeks post-surgery, all patients received direct instruction in physical therapy with a total of 6-8 treatment sessions. After 6 weeks, patients were divided into two groups. Participants in the intervention group received the hospital's standard surgical physiotherapy protocol along with access to a dedicated smartphone application. This application provided daily exercise instruction videos tailored to each rehabilitation phase, automatic reminders, real-time compliance monitoring, and asynchronous communication with the physiotherapist for remote feedback and progress tracking. Participants in the control group received only the hospital's standard surgical physiotherapy protocol and were explicitly instructed not to use any additional rehabilitation applications or online exercise programs throughout the 24-week study period. All participants followed the same standard three-phase rehabilitation protocol developed by the hospital's Department of Rehabilitation based on the Vietnamese Ministry of Health guidelines and Massachusetts General Hospital: Phase 1 (weeks 0-6): Assisted passive protection and movement. Phase 2 (weeks 6-12): Active movement, starting with light resistance. Phase 3 (weeks 12-24): Gradual strengthening and rehabilitation. Assessment of outcomes was planned at baseline (pre-surgery), 6 weeks, 12 weeks, and 24 weeks post-surgery. The primary endpoint was the change in Constant-Murley and Quick DASH scores from baseline to 24 weeks. Secondary criteria include active range of motion measured by an angle measuring device, isotonic shoulder strength measured by a handheld dynamometer (forward flexion, abduction, external rotation, and internal rotation), visual analog scale (VAS) for pain at rest and during activity, Patient-Specific Functional Scale (PSFS), Tampa Scale of Movement Aversion (TSK-11), Self-Effect Scale of Rehabilitation (SER), Exercise Compliance Scale (EARS), EQ-5D-5L for quality of life, time and extent of return to work, total direct non-medical costs, and number of lost workdays for caregivers. Rotator cuff tendon integrity will be assessed after 24 weeks using ultrasound or MRI. Data will be collected using a standard electronic case report form. When participants are unable to attend in-person consultations, data collection will be conducted through structured telephone interviews or home visits by trained research staff, with the methodology clearly documented for each assessment to allow for sensitivity analysis. The study will be conducted in full compliance with the Helsinki Declaration and the ICH Good Clinical Practice guidelines. This study has been approved by the Medical Ethics Committee of Hanoi Medical University. All participants will provide written informed consent before enrollment.
Interventions
PROCEDURETelerehabilitation
High-quality instructional videos on each stage of the personalized exercise program, with AI-assisted observation and correction for post-surgical rotator cuff tendon repair. Daily automated reminders to keep patients informed of their exercise schedule. Interactive digital log to record completed sessions and pain levels. Asynchronous communication with a physical therapist for guidance and program adjustments. The program is designed to enhance treatment adherence and track patient progress in real time throughout the 6-month rehabilitation period.
PROCEDUREConventional home exercise program
The control intervention consists of a conventional home-based exercise program. Patients will receive: During the first 6 weeks, patients will be trained directly by a physical therapist. A printed brochure containing static illustrations and written step-by-step instructions for the post-operative rotator cuff rehabilitation protocol. Standard verbal education from a physiotherapist during the directly training session. Having digital mobile reminders one time per week; patients are expected to manage their exercise frequency independently. Communication with the medical team is limited to scheduled follow-up visits at the hospital and when called by mobile. This group serves as the active comparator to evaluate the added value of the digital mobile application intervention.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessors responsible for evaluating clinical endpoints, such as the Constant-Murley score, Quick DASH score and range of motion, muscle strength, are blinded to the treatment group assignment of the participants to ensure objectivity.
Intervention model description
A randomized, two-arm, parallel-group controlled trial. Participants are randomly assigned to either the experimental group (using a remote rehabilitation mobile application) or the control group (receiving conventional paper-based exercise instructions) with a 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Demographics: Individuals aged 18 years or older. * Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving: * Clinical Presentation: Persistent shoulder pain and functional deficits (e.g., positive impingement signs or weakness in abduction/external rotation) consistent with rotator cuff pathology. * Radiological Confirmation: Imaging evidence (MRI or high-resolution ultrasound) of a full-thickness supraspinatus and/or infraspinatus tendon tear. * Tear Characteristics: Small-to-medium-sized tears (maximum diameter \< 5 cm) categorized as reparable by the attending surgeon. * Surgical Procedure: Patients undergoing primary arthroscopic rotator cuff repair (ARCR) utilizing a standardized double-row suture bridge technique. * Rehabilitation Adherence: Commitment to follow the standardized postoperative rehabilitation protocol as prescribed by the study. * Cognitive and Functional Capacity: * Absence of cognitive impairment, with the ability to comprehend and execute complex exercise instructions. * Proficiency in digital literacy, including the regular use of an internet-enabled electronic device (smartphone, tablet, or computer) capable of video-based communication and data transmission. * Documentation and Consent: * Availability of comprehensive medical records, including pre- and postoperative clinical and radiological data. * Provision of written informed consent by the patient or a legal representative prior to enrollment
Exclusion criteria
* Pre-existing or concomitant upper extremity dysfunction unrelated to the rotator cuff tear, including cervical disc herniation, cerebrovascular accident (stroke), traumatic brain injury, cervical spinal cord injury, rheumatoid arthritis with shoulder involvement, or brachial plexus injury. * Complex or irreparable rotator cuff tears, defined as large or massive tears (\> 5 cm), high-grade fatty infiltration of the rotator cuff muscles (Goutallier grade ≥ 3), or inability to achieve secure tendon repair using sutures during arthroscopic surgery. * Postoperative complications that significantly interfere with rehabilitation, such as surgical site infection, nerve injury with paralysis, or severe deltoid muscle damage. * Severe comorbidities that may substantially affect the rehabilitation process or patient safety, including acute coronary syndrome, recent stroke, uncontrolled diabetes mellitus, or other debilitating systemic diseases. * Inability or unwillingness to comply with the study protocol, including failure to attend scheduled follow-up assessments or voluntary withdrawal from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Constant-Murley score from baseline to 24 weeks post-surgery | From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair | The Constant-Murley Shoulder Score is a validated shoulder-specific outcome measure that evaluates pain, activities of daily living, range of motion, and strength (total score 0-100, higher scores indicate better function). The primary outcome is the mean change in Constant-Murley score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group. |
| Change in Quick DASH score from baseline to 24 weeks after arthroscopic rotator cuff repair | From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair | The Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) is a patient-reported questionnaire assessing upper extremity physical function and symptoms (score 0-100, lower scores indicate better function). The primary outcome is the mean change in Quick DASH score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in active range of motion of the operated shoulder from baseline to 24 weeks | Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively | Active range of motion (forward flexion, abduction, external rotation, and internal rotation) measured with a goniometer. Change from pre-operative baseline to 24 weeks will be compared between groups. |
| Change in isometric shoulder strength from baseline to 24 weeks | Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively | Isometric muscle strength of the operated shoulder (forward flexion, abduction, external rotation, and internal rotation) measured with a handheld dynamometer (kg). The mean of three trials is recorded. Change from baseline to 24 weeks will be compared between groups. |
| Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks | Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively | Pain intensity measured using the Visual Analog Scale (VAS 0-10) at rest and during activity. Change from pre-operative baseline to 24 weeks will be compared between the intervention and control groups. |
| Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks | Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively. | The TSK-11 is a patient-reported questionnaire used to assess fear of movement or injury. It consists of 11 items, each scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 11 to 44. A higher total score indicates a higher degree of kinesiophobia (greater fear of movement). |
| Rotator cuff re-tear rate at 24 weeks post-operatively | At 24 weeks after arthroscopic rotator cuff repair | Incidence of rotator cuff re-tear confirmed by ultrasound or MRI at 24 weeks after surgery. The proportion of re-tear will be compared between the tele-rehabilitation group and the control group. |
| Time and level of return to work at 24 weeks | Assessed at 12 weeks and 24 weeks post-operatively | Time (weeks) to return to work and level of return to work (not returned / part-time / full-time same job / full-time heavier duty). These will be compared between groups. |
| Change in Health-related quality of life (EQ-5D-5L) at 24 weeks | Assessed at 24 weeks post-operatively | Health-related quality of life is assessed using the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire. It consists of two parts: the EQ-5D descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from 1 (no problems) to 5 (extreme problems/unable to). These levels are converted into a single index score (typically ranging from 0 to 1, where 1 indicates perfect health). The EQ VAS records the patient's self-rated health on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine) |
| Change in Self-Efficacy for Rehabilitation Scale (SER) at 24 weeks | Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively | The SER scale assesses a patient's belief in their ability to perform rehabilitation tasks. It consists of 12 items, each scored from 0 (not confident at all) to 10 (completely confident). The total score ranges from 0 to 120. Higher scores indicate higher self-efficacy and greater confidence in the patient's ability to successfully engage in the rehabilitation process |
| Change from baseline in Exercise Adherence Rating Scale (EARS) at 24 weeks. | 6 weeks, 12 weeks, 24 weeks post-operatively | The EARS measures the level of adherence to prescribed home exercise programs. It consists of 6 items focusing on adherence behavior. Each item is scored on a 4-point Likert scale from 0 (strongly disagree) to 3 (strongly agree). The total score for this section ranges from 0 to 18. Higher scores represent better adherence to the exercise protocol. |
| Total Direct Non-Medical Costs at 24 weeks. | 24 weeks (accumulated from baseline) | This measure assesses the economic burden of the treatment process. It includes the total accumulated expenses for transportation, meals, and lodging incurred by the patient and their family during hospital visits and rehabilitation sessions over the 24-week period. Data are collected via a structured cost questionnaire. Results are expressed as the total amount in Vietnam Dong (VND) |
| Caregiver Productivity Loss at 24 weeks | 24 weeks (accumulated from baseline) | Caregiver burden is measured by the total number of work-days lost by the primary caregiver due to assisting the patient with hospital visits, rehabilitation sessions, or home care activities related to the recovery process. This is recorded as a cumulative number of days over the 24-week study period |
Countries
Vietnam
Contacts
CONTACTPhuong D Pham, MD
Outcome results
None listed