Immersive Virtual Reality for Pain-related Movement Dysfunctions in Patients With Chronic Shoulder Pain: Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pain during shoulder flexion movement
研究概览
简要总结
The goal of this clinical trial is to the use of VRi specified effects on pain, kinesiophobia, fear of pain, disability, self-efficacy, grip strength and range of motion in motion in people with chronic shoulder pain. The main question[s] it aims to answer are:
- Can specific immersive virtual reality software decrease movement-evoked pain in patients with chronic shoulder pain compared to non-specific software?
- Can specific immersive virtual reality software increase shoulder flexion range of motion in patients with chronic shoulder pain compared to non-specific software? Participants will use a specific VRi software compared with non-specific VRi software
详细描述
Studio Design Randomized controlled clinical trial (RCT). This protocol follows the indications of the guidelines for Clinical Trial Publications (CONSORT) and will follow the TIDIER check-list for the exhaustive description of the interventions that will be performed.
Target population Patients with persistent musculoskeletal shoulder pain aged 18-65 years primary chronic musculoskeletal pain, according to the International Classification of Diseases-11 (2019) of the International Association for the Study of Shoulder-related Pain (IASP).
Sample size calculation A total of 30 individuals for each treatment group will allow to detect, in numerical variables, differences between pairs of group means of a magnitude (Visual Analogue Pain Scale) corresponding to 1.5 points of the standard deviation, with an effect size of 80% maintaining the type I error at a level of 5%. Taking into account a loss of 10%, it would be necessary to include 33 individuals in each group.
Interventions This is a randomized clinical trial (RCT) of 2 parallel groups (ratio 1:1) that will be carried out in the Teaching Care Unit (UDA) of the Faculty of Health Sciences of the University of Malaga (UMA). The study protocol conforms to the items of the Recommendations for Interventional Trials (SPIRIT) and the RCT will conform to the Consolidated Standards for Reporting Testing (CONSORT).
Recruitment: Patients will be recruited by invitation to participate via email to the university community, as well as contact with Family Medicine professionals for the referral of patients who meet the inclusion criteria will be invited to participate in the RCT. Doctors involved in the recruitment process will receive a clinical session to ensure that the selection process is carried out according to the inclusion criteria and that participants do not meet the exclusion criteria.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People from 18 to 65 years old
- •Shoulder pain of at least three months of evolution located in the proximal anterolateral region of the shoulder
- •Presenting shoulder pain during movements with a history of traumatic or insidious onset
- •Agree to participate in the study and sign the informed consent
排除标准
- •Shoulder pain resulting from cervical spine dysfunction
- •Cognitive deficits
- •Uso of medications for pain control in the previous 24 hours
- •A history of neurological or psychiatric disorders
- •Adhesive capsulitis syndrome (limited passive range of motion of the shoulder: external rotation < 30°; elevation < 150°)
- •Patients with shoulder instability
- •Previous surgery of the shoulder
研究组 & 干预措施
specific Immersive virtual reality (VRi) software
Intervention group will perform active treatment using Virtual Reality software based on pain education and gamified exercise for gradual exposure to shoulder movement. The game involves visual stimuli and shoulder movement exercises in the shoulder flexion and abduction ranges in real time using immersive glasses located on the head and two controls on both hands. Patients will inhabit an avatar from an egocentric perspective.
The intervention will last 3 sessions / week of 15 minutes, therefore carrying a total duration of two weeks of treatment. Within the intervention will consist of a pill of education in pain neuroscience (PNE) of 1 minute duration, followed by an exposure level that will last 2:30 minutes where a progression will be made in number of ranges of motion and speed. Each session will consist of 2 intervention blocks (PNE + Gradual Exposure pill). The content of the PNE educational pills have been selected according to the objective of the study.
干预措施: Oculus Quest 2 (Device)
non specific Immersive virtual reality (VRi) software
The control group will perform a VRi intervention with the game "Tsuro", which consists of a puzzle-based strategy game where the patient will have to solve a maze by placing pieces. This intervention will attempt to assess the influence of the immersive context and the playful component compared to the intervention group. This treatment will last 3 sessions / week of 15 minutes, therefore taking a total duration of two weeks of treatment with a total of 6 sessions.
干预措施: Oculus Quest 2 (Device)
结局指标
主要结局
Pain during shoulder flexion movement
时间窗: Change from baseline before the intervention and after the intervention up to 1 week
Visual Analogue Pain Scale: Score from 0 to 10
次要结局
- Self-efficacy(Change from baseline before the intervention and after the intervention up to 1 week)
- Range of movement in flexion of the shoulder(Change from baseline before the intervention and after the intervention up to 1 week)
- Disability(Change from baseline before the intervention and after the intervention up to 1 week)
- Kinesiophobia(Change from baseline before the intervention and after the intervention up to 1 week)
- Fear of pain(Change from baseline before the intervention and after the intervention up to 1 week)
- Hand grip strength(Change from baseline before the intervention and after the intervention up to 1 week)
- Age(Change from baseline before the intervention and after the intervention up to 1 week)
- Sex(Baseline)
- Profession(Baseline)
- Marital status(Baseline)
研究者
Alejandro Luque-Suarez
Head of Physiotherapy Departament
University of Malaga