Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above-Knee Amputees
|ClinicalTrials.gov Identifier: NCT00686764|
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : December 14, 2015
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.
|Condition or disease||Intervention/treatment|
|Neuroma Amputation||Other: Observational|
|Study Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above Knee Amputees|
|Study Start Date :||May 2008|
|Primary Completion Date :||February 2010|
|Study Completion Date :||February 2010|
Trans-femoral amputees that meet the eligibility criteria.
Using ultrasound, we will measure the cross-sectional area of the neuroma at its widest point and compare to the cross-sectional area of the same nerve at the lesser trochanter.
We will be using four different metrics for quantifying the pain experience of each subject: Questionnaire for Persons with Transfemoral Amputation (Q-FTA), Trinity Amputation and Prosthesis Experience Scales (TAPES), Visual Analog Scale (VAS), and the Short-Form 36 (SF-36).
- Ultrasonic neuroma size [ Time Frame: Single observation at time of consent ]
- Residual limb pain [ Time Frame: Single observation at time of consent ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686764
|United States, Oregon|
|Oregon Health & Science University Center for Health & Healing|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Hans Carlson, M.D.||Oregon Health and Science University|