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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Mexicano del Seguro Social

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Physical Therapy (Telerehabilitation)

    Other intervention

    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 intervention

    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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: TelerehabilitationExperimental treatment 1 intervention
Group B: Conventional RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Shoulder Function

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).

Time frame
Baseline, 12 and 24 weeks

Secondary outcomes

1

Change in Pain Intensity

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).

Time frame
Baseline, 12 and 24 weeks
2

Change in Range of Motion (ROM)

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).

Time frame
Baseline, 12 and 24 weeks
3

Treatment Adherence

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.

Time frame
Baseline, 12 and 24 weeks
4

Patient Satisfaction

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).

Time frame
Baseline, 12 and 24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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