Immersive Virtual Reality Versus Conventional Physiotherapy for Shoulder Tendinopathy

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in Shoulder Pain and Disability Index (SPADI) score [Срок оценки: Baseline and immediately after the 4-week intervention]

Вторичные конечные точки (6)

• Change in pain intensity measured with the Numeric Rating Scale [Срок оценки: Baseline and immediately after the 4-week intervention]
• Change in upper limb function measured with the QuickDASH score [Срок оценки: Baseline and immediately after the 4-week intervention]
• Change in shoulder range of motion [Срок оценки: Baseline and immediately after the 4-week intervention]
• Change in isometric shoulder strength [Срок оценки: Baseline and immediately after the 4-week intervention]
• Change in kinesiophobia measured with the Tampa Scale for Kinesiophobia-11 [Срок оценки: Baseline and immediately after the 4-week intervention]
• Patient satisfaction measured with the Client Satisfaction Questionnaire-8 [Срок оценки: Immediately after the 4-week intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University of Burgos — Burgos

Публикации

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• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available. PMID 10245370
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• Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060. PMID 15866967
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• Kalikanov S, Baizhanova A, Tungushpayev M, Viderman D. Virtual reality for the management of musculoskeletal pain: an umbrella review. Front Med (Lausanne). 2025 Jul 9;12:1572464. doi: 10.3389/fmed.2025.1572464. eCollection 2025. PMID 40703264
• Selles WL, Santos EC, Romero BD, Lunardi AC. Effectiveness of gamified exercise programs on the level of physical activity in adults with chronic diseases: a systematic review. Disabil Rehabil. 2024 Dec;46(26):6231-6239. doi: 10.1080/09638288.2024.2323614. Epub 2024 Mar 5. PMID 38444153
• Vila-Dieguez O, Heindel MD, Awokuse D, Kulig K, Michener LA. Exercise for rotator cuff tendinopathy: Proposed mechanisms of recovery. Shoulder Elbow. 2023 Jun;15(3):233-249. doi: 10.1177/17585732231172166. Epub 2023 May 4. PMID 37325389

Идентификаторы

NCT: NCT07592156 · RHB-HOMVR-2026 · SICEIA-2026-000558

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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