- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03051113
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
February 7, 2019 updated by: Danish Pain Research Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
67
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Danish Pain Research Center, Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with peripheral nerve injury after surgery or trauma.
Amputees.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation.
Time Frame: 3 hours
|
Neuromas identified by ultrasound.
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nina Buch, MD, Department of Anesthesiology, Aarhus University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
February 9, 2017
First Posted (Actual)
February 13, 2017
Study Record Updates
Last Update Posted (Actual)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeuromUL2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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