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NCT Number: NCT07536009

"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 18 years or older.
  • Diagnosis of Subacromial Impingement Syndrome (SIS) based on clinical criteria (pain with overhead activities, painful arc, positive Neer, Hawkins, or Jobe test). Radiological confirmation (ultrasound and/or magnetic resonance imaging) is accepted.
  • Access to the internet and a device (smartphone, tablet, or computer) capable of running the telerehabilitation platform.
  • Willingness and ability to provide written informed consent.

Exclusion criteria

  • Shoulder pain caused by fractures, tumors, infections, or severe systemic pathologies.
  • Previous surgery on the affected shoulder within the last 3 months.
  • Prior joint injection (corticosteroid infiltration) in the affected shoulder within the last 3 months.
  • Subjects with partial or full-thickness rotator cuff tears.
  • Patients currently receiving concurrent physical therapy (PT) or any other external interventions for the shoulder condition.
  • Current participation in another rehabilitation or exercise program.
  • Pregnancy.
  • Cognitive impairment, communication barriers, or any condition that prevents the patient from following the remote instructions.

Treatment and study plan

Digital Physical Therapy (Telerehabilitation)

Other

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.

Conventional physical therapy

Other

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.

Primary outcomes

  1. Change in Shoulder Function

    Time frame: Baseline, 12 and 24 weeks

    Measured by the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). The QuickDASH is an 11-item self-report questionnaire that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome).

Secondary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline, 12 and 24 weeks

    Measured by the Visual Analog Scale (VAS). Participants rate their subjective intensity of pain on a continuous line or numeric rating scale. Scores range from 0 to 10, where 0 indicates "no pain" (best outcome) and 10 indicates the "worst imaginable pain" (worst outcome).

  2. Change in Range of Motion (ROM)

    Time frame: Baseline, 12 and 24 weeks

    Measurement of active and passive range of motion of the affected shoulder using a clinical goniometer. The assessment includes the measurement in degrees of forward flexion, abduction, external rotation, and internal rotation. An increase in degrees indicates an improvement in mobility (better outcome).

  3. Treatment Adherence

    Time frame: Baseline, 12 and 24 weeks

    Defined as the degree to which the participant complies with the prescribed exercise plan. It is calculated as the percentage (%) of completed exercise sessions relative to the total number of scheduled sessions. For the telerehabilitation group, adherence is derived from the Moodle platform metrics (login days, resources accessed, time spent). For the control group, it is manually recorded via the physical therapist's log.

  4. Patient Satisfaction

    Time frame: Baseline, 12 and 24 weeks

    Participant's level of conformity or satisfaction with the assigned rehabilitation program. It is assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates "completely dissatisfied" (worst outcome) and 10 indicates "extremely satisfied" (best outcome).

  5. Long-Term Shoulder Function

    Time frame: 24 weeks postintervention

    Long-term functional outcomes evaluated using the QuickDASH questionnaire. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Carlos Pech Argüelles, MD

CONTACT

[email protected]

9991520786

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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