The Effect of Immersive Virtual Reality on Central Sensitization in People With Chronic Pain: A Proof of Concept Pilot
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
研究概览
简要总结
Patients with chronic low back pain from Dr. Robert Edwards' study at the Brigham & Women's Pain Institute that examines sensory and pain perceptions in patients with chronic pain who use opioids will complete quantitative sensory testing (QST) and current pain levels will be obtained. Subsequently, 20-minutes of Immersive Virtual Reality (IVR) will be completed and then QST testing will be completed again post-IVR.
详细描述
We will partner with Dr. Robert Edwards at the Brigham & Women's Pain Institute. Dr. Edward's is an expert in testing central sensitization using quantitative sensory testing (QST).12 QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways.13 QST identifies the intensity of stimuli (touch) is needed to feel something (threshold of detection) and how perception of stimuli changes if it is repeated many times (temporal summation).14 In people with central sensitization, even light intensity of stimulation is perceived as pain and similar intensity stimuli becomes more painful with multiple applications. We hypothesize that people with chronic pain will demonstrate clinically important reductions in the threshold of detection and temporal summation after IVR, which will demonstrate that IVR can affect central sensitization.
We will complete two types of QST testing: Mechanical Pressure Pain Thresholds (MPPTh) to test for threshold of detection, and Mechanical Temporal Summation of Pain (MTSP) to test for temporal summation. In MPPTh we will measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants. In MTSP we will apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
During the study, we will recruit 20 patients with chronic low back pain from Dr. Edwards' study examining sensory and pain perceptions in patients with chronic pain who use opioids. We will complete QST testing and obtain current pain levels. We will complete 20-minutes of IVR, and then complete QST testing again. We will compare pre-IVR MPPTh and MTSP with post IVR levels. We anticipate short term, clinically important decreases in QST levels providing initial confirmation that IVR can positively change central sensitization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CLBP lasting for more than 6 months as the primary complaint
- •Typical pain ratings ≥ 4/10 on a visual analogue scale
- •Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician.
- •able to speak and understand English
排除标准
- •Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
- •current (i.e., active) substance use disorder (SUD).
- •history of myocardial infarction or other serious cardiovascular condition.
- •current peripheral neuropathy.
- •current pregnancy, or intention to become pregnant during the study.
- •current intrathecal pump
- •history of seizures
- •history severe motion sickness
研究组 & 干预措施
All participants
Quantitative sensory testing will be completed and current pain levels obtained. 20-minutes of immersive virtual reality will be completed, and then complete quantitative sensory testing again. We will compare pre-IVR quantitative sensory testing with post IVR levels.
干预措施: Immersive Virtual Reality (Device)
结局指标
主要结局
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
时间窗: Completed immediately after IVR intervention: Approximately 5 minutes
Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
时间窗: Completed immediately after IVR intervention: Approximately 5 minutes
Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
时间窗: Completed immediately after IVR intervention
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
PANAS
时间窗: Completed immediately after IVR intervention
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)
时间窗: Completed immediately prior to IVR intervention: Approximately 5 minutes
Test for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)
时间窗: Completed immediately prior to IVR intervention: Approximately 5 minutes
Test for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
PANAS
时间窗: Completed immediately prior to IVR intervention
Two scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
时间窗: Completed immediately prior to IVR intervention
Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as "none", 10 as "worst possible"
次要结局
- Simulator Sickness Questionnaire(Completed immediately after IVR experience)
- IGroup Presence Questionnaire(Completed immediately after IVR experience)
研究者
Nancy Baker
Associate Professor
Tufts University