Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain: In-Person Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Changes in Pain Intensity
研究概览
简要总结
After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The proposed work will contrast the efficacy of two virtual reality treatments for phantom limb pain: a 'Distractor' and an Active VR treatment. In the Distractor treatment, participants are engaged in a visually immersive virtual reality experience that does not require leg movements (REAL i-Series® immersive VR experience). In the Active VR treatment, subjects play a series of VR games using the virtual rendering of both legs.
详细描述
Almost 2 million people in the US have had an amputation and up to 90% of people with limb amputation experience the persistent sensation of the missing extremity, a phenomenon known as a "phantom limb" (Weeks et al., 2010). Additionally, a significant proportion of individuals with a phantom limb - up to 85% in some studies - experience persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (hereafter PLP). Although existing therapies provide pain relief in some cases, there is widespread agreement that current approaches fall short of bringing relief to most individuals with PLP (Weeks et al., 2010).
The investigators recently completed a proof-of-concept study (Ambron et al., 2021) in which eight subjects with below knee amputations (BKA) underwent two virtual reality (VR) treatments for PLP. In an Active VR treatment, subjects played a variety of active games requiring leg movements while receiving high-quality visual feedback of the missing lower leg. Feedback about leg position was provided via an electromagnetic system using leg sensors (trackSTAR, Ascension Technologies Inc), and the program generated an image of the missing lower leg, visible as a first-person avatar. This treatment was contrasted with a "Distractor" treatment, in which participants were engaged in a visually immersive virtual reality experience that did not require leg movements (Cool!TM). Both treatments were associated with significant reductions in pain intensity, but the Active VR treatment was also associated with reductions in pain interference, depression, and anxiety.
The specific aims of the current study are (i) to replicate our prior observations of efficacy of VR treatment in a larger sample of individuals with BKA; (ii) to test VR therapy in patients with above knee amputations; (iii) to compare the efficacy of Active VR treatment to Distractor VR treatment for PLP on measures of pain as well as psychological health and quality of life.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 100 years
- •Capacity to provide Informed Consent
- •Unilateral above or below knee amputation more than 3 months prior to enrollment
- •Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater
- •Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.
排除标准
- •History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
- •History of significant or poorly controlled psychiatric disorders
- •Current significant depression or anxiety as judged by the Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983).
- •Current abuse of alcohol or drugs, prescription or otherwise
- •Nursing a child, pregnant, or intent to become pregnant during the study
研究组 & 干预措施
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).
干预措施: VR treatment for phantom limb pain (Behavioral)
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.
干预措施: VR treatment for phantom limb pain (Behavioral)
结局指标
主要结局
Changes in Pain Intensity
时间窗: Baseline versus immediately post-intervention at 4 weeks.
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)
Changes in Pain Quality
时间窗: Baseline versus immediately post-intervention at 4 weeks.
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.
次要结局
- Changes in Average Pain(1st treatment versus 8th treatment (4 weeks))
研究者
Laurel Buxbaum
Institute Scientist, Moss Rehabilitation Research Institute
Albert Einstein Healthcare Network