Neuropathic PainNCT03051113
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
An observational study of Neuropathic Pain and Neuroma, run by Danish Pain Research Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain, Neuroma
- How many people
- 67 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral nerve injury after surgery or trauma. Amputees.
Who may be able to join
- Subjects with peripheral nerve injury 3 months prior to participation
- Subjects with amputation 3 months or more prior to participation
Who cannot join
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
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.
- Conditions
- Neuropathic Pain, Neuroma
- Medical subject headings
- Neuralgia, Neuroma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation.
Neuromas identified by ultrasound.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startAug 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Buch, MD, Principal investigator, Department of Anesthesiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051113
- Sponsor's protocol ID
- NeuromUL2016
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
- ClinicalTrials.gov ID
- NCT03051113
- Acronym / sponsor ID
- NeuromUL2016
- Conditions
- Neuropathic Pain, Neuroma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral nerve injury after surgery or trauma. Amputees.
Key inclusion criteria (2 listed)
- Subjects with peripheral nerve injury 3 months prior to participation
- Subjects with amputation 3 months or more prior to participation
Key exclusion criteria (3 listed)
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation.
Time frame: 3 hours
Neuromas identified by ultrasound.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Buch, MD principal investigator
Department of Anesthesiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Neuroma, run by Danish Pain Research Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation. (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.