Trials / Not Yet Recruiting
Not Yet RecruitingNCT07536009
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Instituto Mexicano del Seguro Social · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial is to determine whether a telerehabilitation program is non-inferior to a conventional rehabilitation program in patients with subacromial pain. Subacromial pain is a prevalent musculoskeletal condition, and while therapeutic exercise is the cornerstone of conservative management, adherence to home programs is often low. Conversely, conventional in-person physical therapy presents logistical and economic barriers for patients. This study aims to evaluate if a well-designed telerehabilitation program, utilizing information and communication technologies for remote monitoring, can provide an effective, accessible, and non-inferior alternative to conventional care. The primary outcome measured will be the change in shoulder function utilizing the QuickDASH questionnaire at 12 weeks. Secondary outcomes will assess pain intensity (VAS), range of motion (ROM), treatment adherence, and long-term functional outcomes.
Detailed description
Chronic subacromial pain represents a significant public health challenge and the most common musculoskeletal disorder after back and neck pain. Its etiology is multifactorial, causing substantial functional limitations, work disability, and a decrease in quality of life. The management of subacromial pain is primarily conducted through conservative interventions, with therapeutic exercise constituting the cornerstone of treatment to reduce joint pain, optimize shoulder function, and improve muscle strength. Despite its efficacy, adherence to home exercise programs is often low due to a lack of supervision and motivation, which compromises long-term outcomes. While supervised, conventional in-person physical therapy improves adherence and functional outcomes, it presents significant logistical and economic barriers, such as travel costs, distance, and difficulty accommodating appointments within work schedules. This creates a gap in care, preventing many patients from receiving the necessary amount of therapy for optimal recovery. Telerehabilitation, a remote healthcare delivery modality utilizing information and communication technologies, emerges as a promising solution to mitigate these barriers. Assisted digital therapy programs can be utilized to maximize treatment intensity, provide real-time biofeedback, and allow physical therapists to progressively adjust exercise complexity under remote guidance. This approach can potentially improve treatment adherence and reduce indirect costs for patients by eliminating travel needs and decreasing time off work. Although current evidence provides compelling data regarding the efficacy of telerehabilitation, establishing its superiority over static home exercise programs, there is a lack of standardized protocols. Furthermore, a clear consensus has not been established regarding its non-inferiority to the conventional in-person model within a standard, non-pandemic clinical setting. To address this gap, this study proposes a prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial. The primary objective is to compare the change in shoulder function, as measured by the QuickDASH, at the end of a 12-week program between a telerehabilitation group and a conventional rehabilitation group. Secondary objectives include comparing changes in pain intensity (VAS) and range of motion (flexion, abduction, and external rotation), as well as evaluating treatment adherence, patient satisfaction, and long-term functional outcomes at 6 months. Answering this question will lay the groundwork for establishing a standardized, evidence-based telerehabilitation protocol as a highly accessible and sustainable care modality for patients with subacromial pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Digital Physical Therapy (Telerehabilitation) | Multimodal digital intervention delivered via the Moodle platform. It includes a structured therapeutic exercise program (mobility, stretching, and progressive strengthening of rotator cuff and periscapular muscles), asynchronous remote monitoring by a physical therapist, and digital health education. Cognitive-behavioral therapy (CBT) components focused on pain reconceptualization and coping strategies are also integrated. Patients perform 30-minute daily sessions, 3-4 times per week, for a duration of 12 to 24 weeks. |
| OTHER | Conventional Physical Therapy | Standard in-person rehabilitation program conducted at the clinic. The intervention consists of supervised therapeutic exercises (similar to the experimental group), manual therapy techniques (joint mobilization and soft tissue manipulation as clinically indicated), and verbal health education provided by the physical therapist. Patients attend 2-3 in-person sessions per week, each lasting 30 minutes, for 12 to 24 weeks, complemented by printed home exercise instructions. |
Timeline
- Start date
- 2026-04-15
- Primary completion
- 2026-12-31
- Completion
- 2027-05-30
- First posted
- 2026-04-17
- Last updated
- 2026-04-17
Source: ClinicalTrials.gov record NCT07536009. Inclusion in this directory is not an endorsement.