Clinical trial NCT00686764: Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above-Knee Amputees
Official title: Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above Knee Amputees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroma Amputation
Keywords: trans-femoral amputation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-05-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* greater than 18 years old
* a trans-femoral amputee
* more than one year post-amputation
* has worn a prosthesis within the last year

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ultrasonic neuroma size
timeFrame: Single observation at time of consent
measure: Residual limb pain
timeFrame: Single observation at time of consent
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University Center for Health & Healing
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Hans Carlson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: