Efficacy of Immersive Virtual Reality Compared With Conventional Physiotherapy in the Management of Shoulder Tendinopathy: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Shoulder Pain and Disability Index (SPADI) score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conventional Therapeutic Exercise (Other)
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.
干预措施: Immersive Virtual Reality-Based Therapeutic Exercise (Other)
结局指标
主要结局
Change in Shoulder Pain and Disability Index (SPADI) score
时间窗: 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.
次要结局
- 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)
- Patient satisfaction measured with the Client Satisfaction Questionnaire-8(Immediately after the 4-week intervention)
研究者
OLALLA SAIZ VAZQUEZ
Occupational Therapyst
Universidad de Burgos