Virtual Mirror Therapy for Relief of Chronic Phantom Limb Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change from Baseline Numeric Rating Scale at Session 2
研究概览
简要总结
The purpose of this project is to further investigate the use of Virtual Mirror therapy for alleviating symptoms of chronic phantom limb pain. This initial pilot study will inform a fully powered randomized control trial which will include both upper and lower extremity amputees
详细描述
Ten unilateral upper extremity amputees suffering from chronic phantom limb pain > 1 yr will be recruited from a hospital based outpatient Physical Medicine and Rehabilitation Amputee Clinic. There will be no control group and all 10 subjects will be offered the use of a Virtual Reality headset therapy game (developed in Unreal Engine using Oculus Quest 2 SDK). Fiducial markers will be placed on the residual limb for tracking via front facing cameras on the Oculus Quest 2 and the sound limb movements will be duplicated (flipped for chirality) and mapped onto the residual limb to provide the appearance of their residual limb. The software will direct the subjects through a series of guided movements, stretches, and visualization exercises which last a total of 15 minutes. Afterwards the subjects will be given 5 minutes of unstructured time in the program to perform any of exercises or movements they desire in order to attempt to relieve their phantom limb pain. Subjects will aim for 1 session per week for a total of 6 weeks. Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability
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
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of unilateral upper extremity amputation with continued intermittent or persistent phantom limb pain symptoms > 1 yr after amputation, pain must be >=4 of 10 on the VAS at least intermittently (i.e. can have no pain at times but they must at least have 4/10 intensity of pain when pain does occur).
排除标准
- •Uncontrolled bipolar/schizophrenia, active psychosis, uncontrolled seizure disorder, history of severe simulator sickness, active nausea/vomiting, uncontrolled vertigo, bilateral blindness, any facial wounds around the cheeks nose or eyes that may interfere with headset, conjunctivitis, zoster ophthalmicus, immunodeficiency (uncontrolled HIV, immuno-suppressive medications, chemotherapy, etc), severe claustrophobia.
结局指标
主要结局
Change from Baseline Numeric Rating Scale at Session 2
时间窗: Week 2 - Week 52
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Baseline Numeric Rating Scale of Chronic Phantom Limb Pain
时间窗: Baseline (Week 0)
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) at Baseline to use as comparison to each study session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well.
Change from Baseline Numeric Rating Scale at Session1
时间窗: Week 1 - Week 52
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Pain Disability Questionnaire at Week 6
时间窗: 6 weeks after final session (Session 6)
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Change from Baseline Numeric Rating Scale at Session 3
时间窗: Week 3 - Week 52
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 4
时间窗: Week 4 - Week 52
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 5
时间窗: Week 5 - Week 52
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Change from Baseline Numeric Rating Scale at Session 6
时间窗: Week 6 - Week 52
Subjects will rate their phantom limb pain symptoms on the Numeric Rating Scale (NRS) prior to and after each session. If pain is intermittent or constant will be noted and if episodic/intermittent a frequency for how often the pain occurs will be obtained as well as if the pain is improved, unchanged, or worsened compared to baseline (prior to study).
Baseline Pain Disability Questionnaire of Chronic Phantom Limb Pain
时间窗: Baseline (Week 0)
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
Change from Baseline Pain Disability Questionnaire at Week 12
时间窗: 12 weeks after final session (Session 6)
Prior to the first session as well as at 6 weeks and 12 weeks subjects will rate their phantom limb pain symptoms on the Pain Disability Questionnaire (PDQ).
次要结局
- Change in Quality from Baseline Chronic Phantom Limb Pain at Session 2(Week 2 - Week 52)
- Change in Quality from Baseline Chronic Phantom Limb Pain at Session 4(Week 4 - Week 52)
- Change in Quality from Baseline Chronic Phantom Limb Pain at Session 3(Week 3 - Week 52)
- Change in Quality from Baseline Chronic Phantom Limb Pain at Session 5(Week 5 - Week 52)
- Change in Quality from Baseline Chronic Phantom Limb Pain at Session1(Week 1 - Week 52)
- Change in Quality from Baseline Chronic Phantom Limb Pain at Session 6(Week 6 - Week 52)
- Impressions of change from Baseline Chronic Phantom Limb Pain at Session 6(Week 6 - Week 52)
研究者
Conley Carr
Assistant Professor
University of Alabama at Birmingham