Effects of Terminal Visual Feedback Therapy After Immersive Virtual Reality in Patients With Chronic Shoulder Pain : Mixed-Methods Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Range of movement in flexion of the shoulder
研究概览
简要总结
The goal of this clinical trial is effect of terminal visual feedback therapy following the use of immersive virtual reality(VRi) effects on pain,kinesiophobia, fear of pain, disability, self-efficacy, grip strength and range of motion in motion in people with chronic shoulder pain compare with just VRi. The main question[s] it aims to answer are:
- Can terminal visual feedback therapy following the use of immersive virtual reality software decrease movement-evoked pain in patients with chronic shoulder pain compared with just VRi?
- Can terminal visual feedback therapy following the use of immersive virtual reality software increase shoulder flexion range of motion in patients with chronic shoulder pain compared with just VRi?
Participants will use a visual feedback therapy following the use of immersive virtual reality software compared with just specific VRi software
详细描述
Studio Design Mixed-methods investigation with 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.
For the qualitative part, a semi-structured interview will be carried out following the indications proposed in the guide for qualitative research publications (COREQ) 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 11 individuals for each treatment group will allow to detect, in numerical variables, differences between pairs of group means of a corresponding magnitude (Flexion range of motion) at 10 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 12 individuals in each group.
Study variables For the qualitative part of the study, a semi-structured interview will be conducted at the beginning of the study and at the end of it, with the same questions in measurements. The questions have been selected and adapted to the persistent shoulder pain of the clinical interview proposal of O'Sullivan et. Al based on functional cognitive therapy (CFT)
- How safe do you feel doing the things in your life that you value?
- How has pain impacted your life?
- What do you think will happen if you lift your shoulder?
- How do you feel when you lift your shoulder?
- How do you feel about the pain?
- Is pain predictable for you? The interviews will be recorded by the principal investigator in order to analyze patients' beliefs and perceptions regarding their shoulder pain, and if there are changes after the intervention.
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 a dysfunction of the cervical spine.
- •Cognitive deficits
- •Uso of medicines 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
- •Rheumatic diseases
研究组 & 干预措施
Terminal visual feedback therapy plus Immersive Virtual reality
Active treatment using Virtual Reality software based on pain education and gamified exercise for gradual exposure to shoulder movement.
The brief intervention will last 3 sessions of 15 minutes during a week, thus taking a total duration of one week 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. Subjects will be recorded through an Ipad Tablet, and after performing the entire intervention a terminal visual feedback therapy will be performed by observation of actions in holocentric vision.
干预措施: Oculus Quest II (Device)
Immersive Virtual Reality
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 brief intervention will last 3 sessions of 15 minutes during a week, thus taking a total duration of one week 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 II (Device)
结局指标
主要结局
Range of movement in flexion of the shoulder
时间窗: Change from Baseline after the intervention up to 1 day
Digital Goniometry: Scores 0-180 grades
Pain during shoulder flexion movement
时间窗: Change from Baseline after the intervention up to 1 day
Visual Analogue Pain Scale: scores 0-10
次要结局
- Hand grip strength(Change from Baseline after the intervention up to 1 day)
- Pain Self-efficacy(Change from Baseline after the intervention up to 1 day)
- Disability(Change from Baseline after the intervention up to 1 day)
- Kinesiophobia(Change from Baseline after the intervention up to 1 day)
- Age(Baseline)
- Sex(Baseline)
- Profession(Baseline)
- Marital Status(Baseline)
- Fear of pain(Change from Baseline after the intervention up to 1 day)
- Risk Chronicity(Change from Baseline after the intervention up to 1 day)
研究者
Alejandro Luque-Suarez
Head of Physiotherapy Departament
University of Malaga