Immersive Virtual Reality Versus Conventional Physiotherapy for Shoulder Tendinopathy

NCT07592156 | Not Yet Recruiting

• 2 other identifiers: RHB-HOMVR-2026SICEIA-2026-000558
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shoulder Tendinopathy

Keywords

rotator cuff tendinopathy; shoulder pain

Outcome Measures

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.

  Baseline and immediately after the 4-week intervention

Secondary Outcomes (6)

• Change in pain intensity measured with the Numeric Rating Scale

  Baseline and immediately after the 4-week intervention

• Change in upper limb function measured with the QuickDASH score

  Baseline and immediately after the 4-week intervention

• Change in shoulder range of motion

  Baseline and immediately after the 4-week intervention

• Change in isometric shoulder strength

  Baseline and immediately after the 4-week intervention

• Change in kinesiophobia measured with the Tampa Scale for Kinesiophobia-11

  Baseline and immediately after the 4-week intervention

Study Arms (2)

Conventional Therapeutic Exercise

ACTIVE COMPARATOR

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

Immersive Virtual Reality-Based Physiotherapy

EXPERIMENTAL

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

Interventions

Conventional Therapeutic Exercise OTHER

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

Conventional Therapeutic Exercise

Immersive Virtual Reality-Based Therapeutic Exercise OTHER

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.

Immersive Virtual Reality-Based Physiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

University of Burgos

Burgos, 09001, Spain

Location

Related Publications (10)

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  PMID: 686873 BACKGROUND

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  PMID: 10245370 BACKGROUND

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  PMID: 16055269 BACKGROUND

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  PMID: 15866967 BACKGROUND

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  PMID: 11188601 BACKGROUND

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  PMID: 40703264 BACKGROUND

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  PMID: 38444153 BACKGROUND

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  PMID: 40165544 BACKGROUND

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  PMID: 36476476 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Olalla Saiz Vazquez, phd

CONTACT

+34625685700; osaiz@ubu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapyst

Model Details: Randomized, open-label, single-center, controlled pilot study with two parallel groups. Participants with shoulder tendinopathy will be assigned to either conventional physiotherapy or an immersive virtual reality-based therapeutic exercise program. Both groups will receive 12 supervised sessions over 4 weeks.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)