Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above-Knee Amputees
Condition: Neuroma Amputation
MeSH terms: Neuroma
Study type: Observational

Summary: 
      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.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): 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).
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will consist of 25 trans-femoral amputees meeting the inclusion and exclusion
        criteria. We will recruit participants from the OHSU clinics, Primary Care Clinics, and
        specialty clinics including orthopaedic surgery, general surgery, pain centers, neurology,
        and orthotics and prosthesis clinics and offices. We anticipate that the majority of
        subjects will be recruited from the Department of Orthopaedics and Rehabilitation's
        clinical practice. Potential subjects will be identified from the investigators' clinic and
        medical records. Recruiting outside of the Department of Orthopaedics and Rehabilitation
        will be done using recruiting posters and letters addressed to the primary care physicians,
        specialists and at prosthetic clinics. Recruitment notices will be posted on the OHSU and
        Department of Orthopaedics and Rehabilitation's Web sites and the OHSU Study Participation
        Web site. We intend to enroll 30 subjects.
      
Keywords: trans-femoral amputation