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

This study has been completed.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00686764
First received: May 27, 2008
Last updated: August 10, 2011
Last verified: May 2008
  Purpose

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 Intervention
Neuroma Amputation
Other: Observational

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above Knee Amputees

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Ultrasonic neuroma size [ Time Frame: Single observation at time of consent ] [ Designated as safety issue: No ]
  • Residual limb pain [ Time Frame: Single observation at time of consent ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Trans-femoral amputees that meet the eligibility criteria.
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).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686764

Locations
United States, Oregon
Oregon Health & Science University Center for Health & Healing
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Hans Carlson, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Hans Carlson, M.D., Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00686764     History of Changes
Other Study ID Numbers: OHSUIRB#3862
Study First Received: May 27, 2008
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
trans-femoral amputation

Additional relevant MeSH terms:
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014