Neuromas as the Cause of Pain

NCT ID: NCT02930551

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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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. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.

Detailed Description

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Conditions

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Neuropathic Pain Neuroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lidocaine

Lidocaine 2 ml injection with 2% Adrenaline

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Isotonic Saline

Isotonic Saline 2 ml Injection

Group Type PLACEBO_COMPARATOR

Isotonic Saline

Intervention Type DRUG

Interventions

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Lidocaine

Intervention Type DRUG

Isotonic Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with peripheral nerve injury 3 months prior to participation

Exclusion Criteria

* Severe somatic or psychiatric diseases
* Other peripheral neuropathy
* Lack of ability to cooperate to the clinical examination
* Allergy to Lidocaine or similar analgetics
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Danish Pain Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danish Pain Research Center, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Neurom2016

Identifier Type: -

Identifier Source: org_study_id

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