跳至主要内容
临床试验/NCT06956508
NCT06956508Enrolling By Invitation不适用

Assessing the Impact of Prophylactic Targeted Brain Rehabilitation (TBR) on Phantom Limb Pain in the Perioperative Period Following Major Amputation, A Prospective Study

OrthoCarolina Research Institute, Inc.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
2
主要终点
Short Form McGill Pain Questionnaire (SF-MPQ)

研究概览

简要总结

This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP).

详细描述

Phantom limb pain (PLP) affects 60-80% of amputees, including both upper and lower extremity amputees, leading to increased anxiety, depression, and reduced quality of life. With the total prevalence of major limb amputees in the United States projected to reach 3 million by 2050 and approximately 185,000 new cases annually, there is a pressing need for effective interventions to prevent and manage PLP.

Current pharmacologic treatments offer limited relief and can lead to adverse outcomes, particularly with long-term opioid use. Non-pharmacologic alternatives, such as mirror therapy, lack strong evidence supporting their efficacy and, to our knowledge, have not been evaluated in the perioperative period.

Virtual reality (VR) has emerged as a promising tool for mitigating various aspects of the phantom limb experience in major limb amputees. Previous research has shown that VR treatments can significantly reduce PLP, with many studies reporting a drop in numeric pain scores after VR use, and can be cost-effective. However, current literature on VR therapy for PLP has never evaluated its use in the immediate post operative period.

Initiating VR therapy immediately post-amputation may help in preventing maladaptive cortical reorganization, which is believed to be a key factor in the development of PLP. Following amputation, the sensory-motor cortex undergoes rapid rewiring as the brain attempts to compensate for the loss of sensory input from the amputated limb. This reorganization can lead to the formation of aberrant neural connections, contributing to the perception of phantom limb sensations and pain. By providing a virtual representation of the missing limb and facilitating its movement, VR therapy may be able to help maintain the integrity of the sensory-motor cortex, potentially preventing or reducing the development of PLP.

Our research team hypothesizes that prophylactic use of Targeted Brain Rehabilitation (TBR), a VR-based therapy system, in the perioperative period following major amputation can prevent or reduce the development of PLP and decrease the usage of opioids in this population. Furthermore, introducing VR therapy in the immediate post-operative period could help mitigate the psychological distress associated with amputation. By addressing both the physical and psychological aspects of amputation from the outset, prophylactic VR therapy has the potential to significantly improve the quality of life for amputees and reduce the long-term burden of PLP. Establishing the efficacy of prophylactic TBR in the perioperative period could revolutionize the standard of care for amputees, potentially reducing the incidence and severity of PLP and its associated psychological and quality of life impacts. This study will lay the groundwork for future multi-center, randomized controlled trials to validate the effectiveness of prophylactic TBR and establish it as a potential standard of care for amputees.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 13+ year old patients undergoing major amputation with Dr. Gaston and Dr. Loeffler in the 12-24 months after the start of this study.
  • Ability to read and comprehend English.
  • Willing to use VR daily while in the inpatient setting following major amputation.

排除标准

  • Patients under 12 years of age, and patients aged 13-17 without a legal guardian to give consent.
  • Have used TBR extensively in the past for prior/unrelated amputation.
  • Active uncontrolled mental illness
  • Active neurological disease or cognitive impairment that would interfere with VR therapy or survey completion.
  • Non-English speaking (surveys will only be provided in English)

研究组 & 干预措施

Control Group

No Intervention

The control group will be any patients, 13 years old or older, who underwent major amputation with Dr. Gaston and Dr. Loeffler in 12-24 months before this trial started.

Treatment Group

Active Comparator

The treatment group will be any patients, 13 years of age or older, who undergo major amputation with Dr. Gaston and Dr. Loeffler for 12-24 months after the start of the study.

干预措施: Targeted Brain Rehabilitation (Other)

结局指标

主要结局

Short Form McGill Pain Questionnaire (SF-MPQ)

时间窗: Through study completion, an average of 1 year

Assesses quality/intensity of their pain experience using descriptive words. Consists of 15 descriptors rated on an intensity scale. Includes visual analog scale (VAS). Administered to both groups. One composite score.

次要结局

  • Numeric Pain Rating Scale (NPRS)(Through study completion, an average of 1 year)
  • Brief Pain Inventory (BPI) - Short Form(Through study completion, an average of 1 year)
  • Phantom Limb Experience Survey(Through study completion, an average of 1 year)
  • Phantom Limb Assessment(Through study completion, an average of 1 year)
  • Simulator Sickness Questionnaire(Through study completion, an average of 1 year)
  • System Usability Scale (SUS)(Through study completion, an average of 1 year)
  • Overall VR experience and feedback survey(Through study completion, an average of 1 year)
  • EuroQol five-dimensional health questionnaire (EQ-5D-5L)(Through study completion, an average of 1 year)
  • Patient Health Questionnaire-9 (PHQ-9)(Through study completion, an average of 1 year)
  • Daily Pain Log - Additional Questions(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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