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Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations

Sponsor
Danish Pain Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT03051113
Collaborator
(none)
67
Enrollment
1
Location
28
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. In this observational cohort study, the investigators wish to explore if the prevalence of neuromas are higher in patients with pain after peripheral nerve injury and amputation, than in patients with the same conditions but without pain.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    67 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
    Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2018
    Actual Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation. [3 hours]

      Neuromas identified by ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects with peripheral nerve injury 3 months prior to participation

    • Subjects with amputation 3 months or more prior to participation

    Exclusion Criteria:

    • Severe somatic or psychiatric diseases

    • Other peripheral neuropathy

    • Lack of ability to cooperate to the clinical examination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danish Pain Research Center, Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

    • Danish Pain Research Center

    Investigators

    • Principal Investigator: Nina Buch, MD, Department of Anesthesiology, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Danish Pain Research Center
    ClinicalTrials.gov Identifier:
    NCT03051113
    Other Study ID Numbers:
    • NeuromUL2016
    First Posted:
    Feb 13, 2017
    Last Update Posted:
    Feb 8, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroma
    Neuralgia
    Peripheral Nerve Injuries

    Study Results

    No Results Posted as of Feb 8, 2019