The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale
研究概览
简要总结
This study will determine if occupational therapy or the combination of occupational therapy and virtual reality is the better treatment for chronic low back pain (CLBP)patients.
详细描述
Chronic musculoskeletal pain is defined as persistent or recurrent pain lasting more than 3 months. Chronic pain is a complex and disabling physiological and psychosocial disorder that does not provide an adaptive or protective purpose. In chronic pain, the precipitating event (e.g., fracture, sprain, trauma) is healed, and yet excessive pain remains. In Immersive Virtual Reality (IVR) people experience a three-dimensional, computer-generated environment via a computer headset. IVR has been used to treat acute pain, but there have been few focused studies on the effects of IVR on chronic pain. When people with chronic pain are in IVR, they become unaware of their body and tend to move normally. We would like to test to see if IVR has a lasting effect in this study. Thus, IVR has strong potential as an additional tool in an arsenal of treatments for chronic pain. This study will examine if IVR can reduce pain and other symptoms in people with chronic pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 and older
- •Referred for chronic pain occupational therapy services at the UPMC Centers for Rehab Services Centre Commons site.
排除标准
- •Had a seizure, loss of awareness, or other symptom linked to an epileptic condition
- •Had virtual reality intervention within the last 3 months
- •Has sensory insensitivity such as hearing loss or low vision, as assessed by the PI
- •Has contagious disorder on the face, such as pink eye, that could be transmitted via the VR headset or has open areas on the face that would come in contact with the headset
- •Has a pacemaker or defibrillator
- •Insufficient upper extremity coordination to operate IVR controls, as assessed by the PI
- •Insufficient cognitive ability to answer questionnaires or learn to use the IVR, as assessed by the PI
- •Have a diagnosis of ASD (Autism Spectrum Disorder) or unable to understand and/or respond in English
研究组 & 干预措施
Occupational Therapy (OT)
Subjects in this treatment group will receive outpatient occupational therapy geared towards people with chronic pain conditions. After obtaining consent, an occupational therapist will meet with the participant to begin their occupational therapy sessions targeted for those who have chronic pain. Additionally, subjects will complete online surveys administered by the therapist before and after each therapy session. There is a total of six 1-hour visits during the 3-month study duration involving occupational therapy. They will also receive online surveys every two weeks and will be asked to complete them at home.
干预措施: Occupational Therapy (Other)
Occupational Therapy + Virtual Reality (OT+VR)
Subjects in this treatment group will receive outpatient occupational therapy intervention geared towards people with chronic pain conditions followed by active, immersive virtual reality sessions. Participants in this treatment group will have 10-30minutes of usual care while receiving 10-30 minutes of virtual reality (e.g. exercises, games, and activities in the virtual world) during each study visit. Subjects will complete online surveys before and after each virtual reality session, along with debriefing from a therapist after each VR session to review what happened and why. Debriefing will include questions to obtain thoughts and narrative information about the participant's experience, as well as overall take-aways from the session. The therapist and subject will also watch a video recording of the subject's VR experience as a method to provide them feedback on their performance. Subjects will receive online surveys every two weeks and will be asked to complete them at home.
干预措施: Occupational Therapy +Virtual Reality (Other)
结局指标
主要结局
Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale
时间窗: Baseline vs 3 months
Numeric Pain Rating questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst pain imaginable." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.
次要结局
- Change from Baseline Pain Intensity at 3 months using PROMIS-29(Baseline vs 3 months)
- Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS)(Baseline vs 3 months)
- Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ).(Baseline vs 3 months)
- Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK).(Baseline vs 3 months)
研究者
Ajay Wasan, MD, Msc
Professor
University of Pittsburgh