Immersive Virtual Reality Versus Conventional Physiotherapy for Shoulder Tendinopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidad de Burgos

About this trial

Immersive virtual reality (VR) has emerged as a promising tool to support therapeutic exercise by increasing patient motivation, promoting movement through gamification, and potentially reducing pain perception during movement. However, evidence regarding its use in shoulder tendinopathy remains limited.

This randomized controlled pilot study will evaluate the clinical efficacy and feasibility of an immersive VR-based exercise program compared with conventional physiotherapy in patients with shoulder tendinopathy. A total of 20 patients referred to the Rehabilitation Department of Hospital Universitario de La Línea de la Concepción will be randomly allocated to either a conventional therapeutic exercise group or an immersive VR-based exercise group. Both interventions will last 4 weeks, with 3 sessions per week, for a total of 12 sessions.

The primary outcome will be shoulder pain and disability measured with the Shoulder Pain and Disability Index (SPADI). Secondary outcomes will include pain intensity, upper limb function, shoulder range of motion, isometric strength, kinesiophobia, and patient satisfaction. Outcomes will be assessed at baseline and immediately after the 4-week intervention

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of shoulder tendinopathy.

Referral to the shoulder rehabilitation program.

Age between 18 and 80 years.

Willingness to use immersive virtual reality headsets.

Disqualifiers

Acute or exacerbated phase of shoulder tendinopathy, defined as resting pain greater than 7 points on a 0-to-10 Numeric Rating Scale.

Simultaneous participation in another clinical study.

Current physiotherapy treatment for the same shoulder condition.

Recent infiltrative treatment within the previous 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Therapeutic Exercise

    Other intervention

    A supervised physiotherapy program consisting of stretching, strengthening, and motor control exercises for the shoulder, delivered over 12 sessions during 4 weeks.

  • Immersive Virtual Reality-Based Therapeutic Exercise

    Other intervention

    A supervised therapeutic exercise program supported by immersive virtual reality. Standalone virtual reality headsets will be used to deliver gamified exercises requiring shoulder movements, including flexion, abduction, and rotation. Virtual reality will be used as a motivational and distractive support tool, not as a replacement for therapeutic exercise principles.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Conventional Therapeutic ExerciseActive comparator 1 intervention
Group B: Immersive Virtual Reality-Based PhysiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Shoulder Pain and Disability Index (SPADI) score

The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability. The SPADI includes pain and disability domains, with scores ranging from 0 to 100. Higher scores indicate greater pain and disability. The primary endpoint will be the change in total SPADI score from baseline to post-intervention.

Time frame
Baseline and immediately after the 4-week intervention

Secondary outcomes

1

Change in pain intensity measured with the Numeric Rating Scale

Pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
Baseline and immediately after the 4-week intervention
2

Change in upper limb function measured with the QuickDASH score

Upper limb function will be assessed using the 11-item QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.

Time frame
Baseline and immediately after the 4-week intervention
3

Change in shoulder range of motion

Shoulder range of motion will be measured using a universal manual goniometer for flexion, abduction, external rotation, and internal rotation. Values will be recorded in degrees.

Time frame
Baseline and immediately after the 4-week intervention
4

Change in isometric shoulder strength

Isometric shoulder strength will be assessed using digital dynamometry for flexion, abduction, internal rotation, and external rotation. Values will be recorded in kilograms

Time frame
Baseline and immediately after the 4-week intervention

Other outcomes

Sponsors and contacts

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