Immersive Virtual Reality Versus Conventional Physiotherapy for Shoulder Tendinopathy (HOMVR)

May 11, 2026 updated by: OLALLA SAIZ VAZQUEZ, Universidad de Burgos

Efficacy of Immersive Virtual Reality Compared With Conventional Physiotherapy in the Management of Shoulder Tendinopathy: A Randomized Controlled Pilot Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Shoulder pain is one of the most common musculoskeletal conditions and is frequently associated with pain, functional limitation, reduced quality of life, and increased healthcare use. Conservative management based on therapeutic exercise is considered a first-line intervention for shoulder tendinopathy. Nevertheless, adherence to conventional exercise programs may be limited by monotony, pain during movement, and fear of movement.

Immersive virtual reality may offer an additional therapeutic strategy by combining supervised exercise with gamified environments that require shoulder movements such as flexion, abduction, and rotation. In this study, VR will be used as a motivational and distractive support tool and not as a replacement for therapeutic exercise principles. The VR intervention will be delivered using standalone immersive VR headsets under direct supervision by the principal investigator.

This is a single-center, prospective, randomized, controlled pilot study with two parallel groups. Participants will be patients aged 18 to 80 years with a confirmed diagnosis of shoulder tendinopathy who are referred to the Rehabilitation Department of Hospital Universitario de La Línea de la Concepción. Participants will be randomized to either the control group, receiving conventional therapeutic exercise, or the experimental group, receiving a VR-based gamified exercise program.

Both groups will complete 12 supervised sessions over 4 weeks. The control group will perform 15 minutes of stretching followed by 30 minutes of strengthening and motor control exercises using sticks, elastic bands, and free weights. The experimental group will perform the same 15-minute stretching warm-up followed by 30 minutes of immersive VR-based gamified exercises designed to elicit therapeutic shoulder movements.

Assessments will be performed at baseline before randomization and after completion of the intervention. The primary outcome will be change in the Shoulder Pain and Disability Index. Secondary outcomes will include pain intensity measured with a numerical rating scale, upper limb function measured with the QuickDASH, shoulder range of motion measured by goniometry, isometric shoulder strength measured by dynamometry, kinesiophobia measured with the TSK-11, and treatment satisfaction measured with the CSQ-8. As this is a pilot study, the sample size has been pragmatically set at 20 participants to explore feasibility, acceptability, and preliminary effect estimates rather than to provide definitive evidence of efficacy.

Study Type

Interventional

Enrollment (Estimated)

20

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

  • Name: Olalla Saiz Vazquez, phd
  • Phone Number: +34625685700
  • Email: osaiz@ubu.es

Study Locations

  • Spain
      • Burgos, Spain, 09001
        • University of Burgos
        • Contact:
          • Olalla Saiz Vazquez
          • Phone Number: 625685700
          • Email: osaiz@ubu.es

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:

  • Confirmed diagnosis of shoulder tendinopathy.
  • Referral to the shoulder rehabilitation program.
  • Age between 18 and 80 years.
  • Willingness to use immersive virtual reality headsets.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • 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.
  • Any condition contraindicating the use of immersive virtual reality, including photosensitive epilepsy, severe vertigo, claustrophobia, or active ocular or facial infections.
  • Intolerance to the use of virtual reality headsets.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Therapeutic Exercise
Participants allocated to the control group will receive a conventional therapeutic exercise program for shoulder tendinopathy. The intervention will consist of 12 supervised sessions over 4 weeks, with 3 sessions per week. Each session will include 15 minutes of stretching followed by 30 minutes of strengthening and motor control exercises using sticks, elastic bands, and free weights.
Other: Conventional Therapeutic Exercise
A supervised physiotherapy program consisting of stretching, strengthening, and motor control exercises for the shoulder, delivered over 12 sessions during 4 weeks.
Experimental: Immersive Virtual Reality-Based Physiotherapy
Participants allocated to the experimental group will receive an immersive virtual reality-based therapeutic exercise program for shoulder tendinopathy. The intervention will consist of 12 supervised sessions over 4 weeks, with 3 sessions per week. Each session will include 15 minutes of stretching followed by 30 minutes of gamified shoulder exercises using immersive virtual reality headsets. The virtual reality exercises will require shoulder flexion, abduction, and rotational movements and will be supervised by the principal investigator.
Other: Immersive Virtual Reality-Based Therapeutic Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Shoulder Pain and Disability Index (SPADI) score
Time Frame: Baseline and immediately after the 4-week intervention
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.
Baseline and immediately after the 4-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity measured with the Numeric Rating Scale
Time Frame: Baseline and immediately after the 4-week intervention
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.
Baseline and immediately after the 4-week intervention
Change in upper limb function measured with the QuickDASH score
Time Frame: Baseline and immediately after the 4-week intervention
Upper limb function will be assessed using the 11-item QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Baseline and immediately after the 4-week intervention
Change in shoulder range of motion
Time Frame: Baseline and immediately after the 4-week intervention
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.
Baseline and immediately after the 4-week intervention
Change in isometric shoulder strength
Time Frame: Baseline and immediately after the 4-week intervention
Isometric shoulder strength will be assessed using digital dynamometry for flexion, abduction, internal rotation, and external rotation. Values will be recorded in kilograms
Baseline and immediately after the 4-week intervention
Change in kinesiophobia measured with the Tampa Scale for Kinesiophobia-11
Time Frame: Baseline and immediately after the 4-week intervention
Kinesiophobia will be assessed using the 11-item Tampa Scale for Kinesiophobia. Each item is scored from 1 to 4, with higher scores indicating greater fear of movement.
Baseline and immediately after the 4-week intervention
Patient satisfaction measured with the Client Satisfaction Questionnaire-8
Time Frame: Immediately after the 4-week intervention
Treatment satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire. Higher scores indicate greater satisfaction with the received intervention.
Immediately after the 4-week intervention

Collaborators and Investigators

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

Sponsor

Universidad de Burgos

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)

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHB-HOMVR-2026
  • SICEIA-2026-000558 (Other Identifier: Comité de Ética de la Investigación Provincial de Cádiz / SICEIA, Junta de Andalucía)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. Data will be pseudonymized and stored securely in accordance with applicable European and Spanish data protection regulations. Aggregated study results may be disseminated through scientific reports or publications.

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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