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临床试验/NCT00686764
NCT00686764已完成不适用

Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above Knee Amputees

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2008年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Carlson

Associate professor of physical medicine and rehabilitation in the Department of Orthopaedics and Rehabilitation

Oregon Health and Science University

研究点 (1)

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