Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above Knee Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Ultrasonic neuroma size
研究概览
简要总结
Background: The formation of neuromas, a fusiform swelling of a nerve or nerve ending, is a well documented response to limb amputation. Likewise, Residual Limb Pain (RLP), pain felt from the remaining portion of the amputated limb, is common among amputees. Neuromas are found in more than 90% of lower extremity amputations, of which 30-50% are pain-generating for the patient . And while surgical techniques reveal the commonly held belief that neuroma formation is one of the causal drivers behind RLP, there has been no study to demonstrate that the two events - namely the magnitude of neuroma formation and the magnitude of pain experienced by amputees - are correlated. If this correlation, or lack thereof, were elucidated with the use of ultrasonography, this would provide the preliminary data which could lead to further studies in neuroma minimization and/or proliferation.
Objective: This study seeks to use ultrasonography (US) to quantify the degree to which neuroma size and the nature of surrounding tissue correlate with the experience of RLP in trans-femoral amputees.
Setting and Subjects: This study will enroll 30 trans-femoral amputees, male and female, who are over the age of 18. The study will take place in the OHSU Orthopaedic Outpatient Clinic, and OHSU Imaging Department.
Intervention: None. This is an observational clinical study in which we will characterize the sciatic nerve/neuroma and surrounding tissue using ultrasound.
Measurements: We will use US to measure the cross sectional area of the neuroma at its widest point and compare this to the cross section of the same neuron at the lesser trochanter. Furthermore, we will describe the morphology of the neuroma. To quantify the subject's pain experience we will utilize the Questionnaire for Persons with Transfemoral Amputation (Q-TFA), Trinity Amputation & Prosthetic Experience Scale (TAPES), Visual Analog Scale (VAS), and the Short Form 36 (SF-36).
Analysis: The statistical analysis will employ a Pearson correlation coefficient and linear regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •greater than 18 years old
- •a trans-femoral amputee
- •more than one year post-amputation
- •has worn a prosthesis within the last year
排除标准
- •subject also diagnosed with diabetes
- •subject also diagnosed with Peripheral Vascular Disease
- •subject also diagnosed with peripheral neuropathy
- •subject with spinal cord, head, or nerve root injury
结局指标
主要结局
Ultrasonic neuroma size
时间窗: Single observation at time of consent
Residual limb pain
时间窗: Single observation at time of consent
次要结局
未报告次要终点
研究者
Hans Carlson
Associate professor of physical medicine and rehabilitation in the Department of Orthopaedics and Rehabilitation
Oregon Health and Science University
