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

11 maja 2026 zaktualizowane przez: 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

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Olalla Saiz Vazquez, phd
  • Numer telefonu: +34625685700
  • E-mail: osaiz@ubu.es

Lokalizacje studiów

      • Burgos, Hiszpania, 09001
        • University of Burgos
        • Kontakt:
          • Olalla Saiz Vazquez
          • Numer telefonu: 625685700
          • E-mail: osaiz@ubu.es

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
A supervised physiotherapy program consisting of stretching, strengthening, and motor control exercises for the shoulder, delivered over 12 sessions during 4 weeks.
Eksperymentalny: 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Shoulder Pain and Disability Index (SPADI) score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in pain intensity measured with the Numeric Rating Scale
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 listopada 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Conventional Therapeutic Exercise

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