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

April 16, 2026 updated by: Roberto Carlos Pech Arguelles, Instituto Mexicano del Seguro Social
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation
A 12- to 24-week digital intervention program including a structured exercise protocol, health education, and cognitive-behavioral therapy (CBT) delivered via the Moodle platform. Exercises focus on mobility, stretching, and gradual strengthening of the shoulder/scapular muscles, recommended 3-4 sessions per week (30 minutes daily).
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.
Active Comparator: Conventional Rehabilitation
High-dose, in-person physical therapy at the clinic. The program includes therapeutic exercises with graded exposure to movement, manual therapy, and verbal education. Recommended 2-3 in-person sessions per week (30 minutes per session), complemented by home exercises.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 12 and 24 weeks
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).
Baseline, 12 and 24 weeks
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.
Baseline, 12 and 24 weeks
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).
Baseline, 12 and 24 weeks
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).
24 weeks postintervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2026-3201-029
  • FMED-001446 (Other Identifier: Universidad Autónoma de Yucatán)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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