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临床试验/NCT05254509
NCT05254509已完成不适用

The Effects of Virtual Reality With Debriefing on Patients With Chronic Pain

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ajay Wasan, MD, Msc

Professor

University of Pittsburgh

研究点 (2)

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