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

Neuroma Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686764
• Other study ID #: OHSUIRB#3862
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: December 10, 2015
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: December 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Neuroma
• Neuroma Amputation

Intervention

Other:
• Observational
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).

Locations

Country	Name	City	State
United States	Oregon Health & Science University Center for Health & Healing	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonic neuroma size		Single observation at time of consent	No
Primary	Residual limb pain		Single observation at time of consent	No