Exploring the Role of Immersive Virtual Reality in Managing Upper-limb Complex Regional Pain Syndrome in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
研究概览
简要总结
This study is designed to test if the use of virtual reality (VR) can improve chronic pain related to CRPS. One way is to use virtual reality. Virtual reality involves looking into a set of goggles and interacting with a computer-simulated world. The use of VR has been shown to be an effective treatment for other pain conditions (Hoffman et al., 2019) and is inexpensive and noninvasive.
详细描述
Participants will "go into" simple fun pain distracting virtual reality worlds (no previous video game experience needed) that encourages physical movement of the injured limb (e.g., their injured hand). They will also learn some simple daily 10 minute stress reduction, mood lifting mindfulness skills in VR and will receive audio instructions to focus their attention on the sights and sounds, and controlled breathing (Flores et al., 2019).
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will not be told there is more than one treatment group, but during the consenting process each participant will be fully informed about the treatment they will personally receive. The statistician will not be told which group received more treatments.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (18+)
- •confirmed diagnosis of either CRPS I or CRPS II of one or both upper limbs (as defined by the Budapest Criteria)
- •average pain score in the affected CRPS limb(s) greater than or equal to 3 out of 10
- •on a stable treatment plan for 4 weeks prior to the VR intervention phase
- •ability to wear a VR head-mounted display
- •ability to speak and read English
- •ability to provide informed consent.
排除标准
- •personal history of severe motion sickness
- •severe systemic disease that is a constant threat to life (ASA class IV+)
- •prisoners.
研究组 & 干预措施
Roosevelt "in clinic VR"
During the "in clinic" training phase of the study, patients in this group will receive VR physical therapy exercises "in clinic" only (no homeworks during training). After the training phase, all patients will do VR homeworks, including VR exercises and VR mindfulness.
干预措施: in clinic pain VR reduction exercises (Behavioral)
Roosevelt "in Clinic VR" + "VR homeworks"
During the training phase, patients in this group will receive VR physical therapy exercises "in clinic". In addition, during the training phase, they will also take a VR system home and will be encouraged to do VR homeworks at home. After the training phase, all patients will do VR homeworks, including VR exercises and VR mindfulness.
干预措施: In clinic VRpain reduction exercises + VR homeworks (Behavioral)
结局指标
主要结局
The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
时间窗: Change from baseline to 1 year post-treatment
This self-report measure. reflects a patient's belief about the efficacy of treatment. Compared with before receiving VR therapy, how would you describe your pain related to CRPS now overall? 7 point scale from - 3 to + 3 (-3 = very much worst, +3 = very much better). This is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change in CRPS pain as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.
时间窗: Change from baseline to one year post-treatment
This self-report measure reflects a patient's belief about the efficacy of treatment. Compared with before receiving VR therapy, how would you describe your physical abilities now overall? 7 point scale from - 3 to + 3 (-3 = very much worst, +3 = very much better). This is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change in physical abilities as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.
时间窗: Change from baseline to 16 weeks
This self-report measure. reflects a patient's belief about the efficacy of treatment. Compared with before receiving VR therapy, how would you describe your pain related to CRPS now overall? 7 point scale from - 3 to + 3 (-3 = very much worst, +3 = very much better). This is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change in CRPS pain as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.
时间窗: Change from baseline to 16 weeks
This self-report measure reflects a patient's belief about the efficacy of treatment. Compared with before receiving VR therapy, how would you describe your physical abilities now overall? 7 point scale from - 3 to + 3 (-3 = very much worst, +3 = very much better). This is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change in physical abilities as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
次要结局
- The Central Sensitization Inventory (CSI).(Change from baseline to one year post-treatment)
- CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.(Change from baseline to one year post-treatment)
- Mindfulness.(Change from baseline to one year post-treatment)
- Pain Catastrophizing Scale.(Change from baseline to one year post-treatment)
- The 8-item PROMIS Sleep Disturbance Short Form.(Change from baseline to one year post-treatment.)
- Quickdash (measure of physical function).(Change from baseline to one year post-treatment.)
- Tampa Scale for Kinesiophobia.(Change from baseline to one year post-treatment.)
- The Central Sensitization Inventory (CSI).(Change from baseline to 16 weeks)
- CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.(Change from baseline to 16 weeks)
- Mindfulness.(Change from baseline to 16 weeks.)
- Pain Catastrophizing Scale.(Change from baseline to 16 weeks.)
- The 8-item PROMIS Sleep Disturbance Short Form.(Change from baseline to 16 weeks.)
- Quickdash (measure of physical function).(Change from baseline to 16 weeks)
- Tampa Scale for Kinesiophobia.(Change from baseline to 16 weeks.)
研究者
Miles Fontenot
Resident: School of Medicine: Anesthesiology & Pain Medicine
University of Washington