虚拟现实治疗幻腿痛的疗效及机制
2026年8月17日 更新者：Laurel Buxbaum、Albert Einstein Healthcare Network
虚拟现实治疗幻腿痛的疗效和机制：面对面治疗
在手臂或腿部截肢后，高达 90% 的受试者会经历“幻肢”，这种现象的特征是持续感觉肢体缺失。
许多患有幻肢的受试者在缺失的肢体中会感到剧烈疼痛，而这种疼痛通常对药物或其他干预措施反应不佳。
拟议的工作将对比两种虚拟现实治疗幻肢痛的疗效：“干扰器”和主动 VR 治疗。
在 Distractor 治疗中，参与者参与不需要腿部运动的视觉沉浸式虚拟现实体验（REAL i-Series® 沉浸式 VR 体验）。
在 Active VR 治疗中，受试者使用双腿的虚拟渲染玩一系列 VR 游戏。
研究概览
详细说明
在美国，将近 200 万人进行过截肢手术，而高达 90% 的肢体截肢患者都经历过肢体缺失的持续感觉，这种现象被称为“幻肢”（Weeks 等人，2010 年）。 此外，很大一部分患有幻肢的人（在一些研究中高达 85%）会在缺失的肢体中经历持续且使人虚弱的疼痛，这种情况称为幻肢痛（以下简称 PLP）。 尽管现有疗法在某些情况下可以缓解疼痛，但人们普遍认为，目前的方法不足以缓解大多数 PLP 患者的疼痛（Weeks 等人，2010 年）。
研究人员最近完成了一项概念验证研究（Ambron 等人，2021 年），其中八名膝下截肢 (BKA) 受试者接受了两次 PLP 虚拟现实 (VR) 治疗。 在 Active VR 治疗中，受试者玩各种需要腿部运动的主动游戏，同时接收缺失小腿的高质量视觉反馈。 关于腿部位置的反馈是通过使用腿部传感器（trackSTAR，Ascension Technologies Inc）的电磁系统提供的，并且该程序生成了缺失的小腿的图像，作为第一人称头像可见。 这种治疗与“干扰者”治疗形成对比，在“干扰者”治疗中，参与者参与不需要腿部运动的视觉沉浸式虚拟现实体验 (Cool!TM)。 两种治疗都与疼痛强度的显着降低有关，但 Active VR 治疗也与疼痛干扰、抑郁和焦虑的减少有关。
当前研究的具体目标是 (i) 在更大的 BKA 个体样本中复制我们之前对 VR 治疗疗效的观察； (ii) 在膝上截肢患者中测试 VR 疗法； (iii) 比较 Active VR 治疗与 Distractor VR 治疗 PLP 在疼痛测量以及心理健康和生活质量方面的疗效。
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Elkins Park、Pennsylvania、美国、19027
- Moss Rehabilitation Research Institute
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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Washington
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Seattle、Washington、美国、98104
- University of Washington-Harborview Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 18 岁 - 100 岁
- 提供知情同意的能力
- 入组前 3 个月以上单侧膝上或膝下截肢
- 没有认知障碍，操作上定义为蒙特利尔认知评估得分为 24 分或更高
- 在麦吉尔疼痛问卷 (Melzack, 1987) 的视觉模拟量表中，幻肢在前 1 个月的平均疼痛评分大于 40
排除标准：
- 有重大医学或神经系统疾病史，例如中风或中度至重度创伤性脑损伤（操作上定义为意识丧失超过 30 分钟）
- 严重或控制不佳的精神疾病史
- 根据医院焦虑和抑郁量表 (HADS)（Zigmond & Snaith，1983）判断的当前严重抑郁或焦虑。
- 当前滥用酒精或药物、处方或其他方式
- 在研究期间护理孩子、怀孕或打算怀孕
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active VR treatment
Subjects assigned to the Active VR treatment began by selecting an avatar, with features such as gender and skin color that could be chosen according to preference.
During treatment, they participated in a variety of games and activities developed and used by our teams including Kick, Dog Food, Quest for Fire, Chess, Checkers, Sudoku, and surfing the internet.
Subjects had substantial flexibility to select games according to their interests but were required to spend at least 30 minutes in each session in games that required forceful, large-amplitude movements of the amputated lower limb (e.g., Quest for Fire, Kick).
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8 twice-weekly interventions of virtual reality treatment focused on reducing phantom limb pain.
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实验性的：Distractor VR treatment
Subjects assigned to the Distractor VR treatment participated in the REAL i-Series immersive VR experience (REAL system), which had been demonstrated to reduce pain in several studies but lacked the hypothesized "active ingredients" of our Active VR treatment (visual and auditory feedback of movement of an extrapolated amputated limb).
Subjects navigated through pleasant and relaxing VR environments; they did not see any rendering of their body and made no movements with their legs.
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8 twice-weekly interventions of virtual reality treatment focused on reducing phantom limb pain.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Pain Intensity
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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Visual Analogue Scale (VAS) of McGill Short Form Questionnaire (Melzack, 1987); 0 minimum score - 10 maximum score; higher scores indicate higher level of pain (worse outcome)
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Baseline versus immediately post-intervention at 4 weeks.
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Changes in Pain Quality
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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McGill Short Form Questionnaire (Melzack, 1987): a series of 4-point scales (0 none - 3 severe) assessing the intensity of 15 qualitative characteristics of pain (e.g., throbbing, shooting, cramping, etc.), where higher scores are worse (more severe).
For every participant we computed the total pain score (maximum 45 points indicating severe pain).
Then, we computed the difference in the total scores between time points (e.g.
post treatment vs baseline).
Therefore, negative scores indicate improvement in pain qualitative characteristics.
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Baseline versus immediately post-intervention at 4 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Average Pain
大体时间：1st treatment versus 8th treatment (4 weeks)
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Difference between 8th and 1st treatment session on scaled score measuring "average pain intensity since the previous intervention" on an 11-point numerical rating pain scale; (Scale = 0 - minimum score/no pain to 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome).
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1st treatment versus 8th treatment (4 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Daily Activities
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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The Frenchay Activities Index (FAI) (Holbrook et al., 1983):1983): a scale measuring the physical function and daily activity associated with quality of life in people with amputation.
Scale = 0 minimum score to 45 maximum score; higher scores indicate more daily activities (better outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
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Baseline versus immediately post-intervention at 4 weeks.
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Changes in Quality of Life
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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The 12-Item Short Form Health Survey (SF-12) (Ware et al., 1996): a measure of quality of life and functional capacity that has been validated in patients with amputation and phantom limb pain.
Scale = 0 minimum score to 100 maximum score.
Higher scores indicate poorer physical and mental health (worse outcome).
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Baseline versus immediately post-intervention at 4 weeks.
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Changes in Pain Interference
大体时间：Baseline versus immediately post-intervention at 4 weeks
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The Pain Interference Scale from the Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994): A scale measuring the degree to which pain interferes with daily activities using a 0-10 numeric rating.
Scale = 0 minimum score to 10 maximum score.
Higher scores indicate greater pain interference (worse outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
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Baseline versus immediately post-intervention at 4 weeks
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Changes in Depression and Anxiety
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983): This is a 14- item measure with subscales assessing depressive and anxiety symptoms.
For each subscale.
range = 0 minimum score to 42 maximum score.
Higher scores indicate more depression and/or anxiety (worse outcome).
We report average differences on the anxiety scale and the depression scales between post-intervention (after 4 weeks) and pre-intervention.
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Baseline versus immediately post-intervention at 4 weeks.
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Changes in Pain Catastrophizing
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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The 13-item Pain Catastrophizing Scale (Sullivan et al., 1995): this scale investigates pain catastrophizing, which has been associated with pain severity and disability after amputation.
Score range = 0-52; Higher scores indicate higher tendency to catastrophize (worse outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
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Baseline versus immediately post-intervention at 4 weeks.
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Changes in Insomnia
大体时间：Baseline versus immediately post-intervention at 4 weeks.
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Insomnia Severity Index (Bastien et al., 2001): a 7-point scale that measures insomnia, a symptom associated with phantom limb pain.
Score range = 0-28; higher scores indicate more insomnia (worse outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
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Baseline versus immediately post-intervention at 4 weeks.
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Acceptance of VR System
大体时间：Baseline
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Technology Acceptance Scale (Morris et al., 1997): this is a 7-point scale that measures level of acceptance of the VR system.
0 minimum score - 133 maximum score; higher scores indicate low level of acceptance (worse score).
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Baseline
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Usability of the Treatment
大体时间：immediately after the last intervention (session 8 of the intervention), an average of 4 weeks
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System Usability Scale (SUS) (Brooke, 1996); Scale measuring the usability of the each game; minimum score 10 - maximum score 50.
Higher scores indicate less usability (worse outcome).
For the distractor treatment, participants rated the overall experience; for the active treatment, the average of the two games was computed for each participants.
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immediately after the last intervention (session 8 of the intervention), an average of 4 weeks
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Cybersickness
大体时间：1st (week 1) and 8th (week 4) treatment sessions
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Simulator Sickness Questionnaire - SSQ (Kennedy et al., 1993): 4 points (0 - none; 3 - severe) scale assessing the severity of 16 cybersickness motion sickness symptoms, like nausea or dizziness.
We computed the average score across items.
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1st (week 1) and 8th (week 4) treatment sessions
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Presence in VR
大体时间：1st (week 1) and 8th (week 4) treatment sessions.
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Brief Slater-Usoh-Steed Presence Questionnaire (Usoh et al., 2000; Slater et al., 1998; 1994).
0 minimum score - 42 maximum score.
Higher scores indicate more presence in the VR (better outcome
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1st (week 1) and 8th (week 4) treatment sessions.
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Changes in Pain at Its Worst
大体时间：Baseline versus immediately post-intervention at 4 weeks
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The Modified Limb Deficiency and Phantom Limb Questionnaire (Goller et al., 2013): a questionnaire and visual analog scale assessing prosthesis usage, phantom limb experiences, and pain severity.
The outcome measure used was the score on the visual analogue scale assessing pain severity at its worst (Scale = 0 no pain to 10 unbearable pain).
We report the average score difference between post-intervention (after 4 weeks) and pre-intervention.
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Baseline versus immediately post-intervention at 4 weeks
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Treatment Satisfaction
大体时间：1 week after the end of the intervention, an average of 5 weeks
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Visual analogue scale that evaluates treatment satisfaction (Robinson et al., 2004; Smith et al., 2005); 0 minimum score - 10 maximum score; Higher scores indicate more treatment satisfaction (better outcome)
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1 week after the end of the intervention, an average of 5 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Laurel Buxbaum, PsyD、Albert Einstein Healthcare Netork
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Robinson LR, Czerniecki JM, Ehde DM, Edwards WT, Judish DA, Goldberg ML, Campbell KM, Smith DG, Jensen MP. Trial of amitriptyline for relief of pain in amputees: results of a randomized controlled study. Arch Phys Med Rehabil. 2004 Jan;85(1):1-6. doi: 10.1016/s0003-9993(03)00476-3.
- Smith DG, Ehde DM, Hanley MA, Campbell KM, Jensen MP, Hoffman AJ, Awan AB, Czerniecki JM, Robinson LR. Efficacy of gabapentin in treating chronic phantom limb and residual limb pain. J Rehabil Res Dev. 2005 Sep-Oct;42(5):645-54. doi: 10.1682/jrrd.2005.05.0082.
- Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
- Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
- Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.
- Ambron E, Buxbaum LJ, Miller A, Stoll H, Kuchenbecker KJ, Coslett HB. Virtual Reality Treatment Displaying the Missing Leg Improves Phantom Limb Pain: A Small Clinical Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1100-1111. doi: 10.1177/15459683211054164. Epub 2021 Oct 27.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月10日
初级完成 (实际的)
2025年3月16日
研究完成 (实际的)
2025年4月6日
研究注册日期
首次提交
2022年2月9日
首先提交符合 QC 标准的
2022年3月24日
首次发布 (实际的)
2022年3月25日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 2022-775.
- 5R01HD104158-05 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
去识别化后，要共享的个体参与者数据将包括临床状态的描述符（例如，自截肢以来的时间、截肢水平）、背景测试电池结果和结果测量结果。
IPD 共享时间框架
发布后立即。
没有结束日期。
IPD 共享访问标准
提供合理理由的研究人员。
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.