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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03051113
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 8, 2019
Information provided by (Responsible Party):
Danish Pain Research Center

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
Neuropathic Pain Neuroma

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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 : August 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation. [ Time Frame: 3 hours ]
    Neuromas identified by ultrasound.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with peripheral nerve injury after surgery or trauma. Amputees.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03051113

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Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
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Principal Investigator: Nina Buch, MD Department of Anesthesiology, Aarhus University Hospital
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Responsible Party: Danish Pain Research Center Identifier: NCT03051113    
Other Study ID Numbers: NeuromUL2016
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Trauma, Nervous System
Wounds and Injuries