Neuromas as the Cause of Pain

February 7, 2019 updated by: Danish Pain Research Center

Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover 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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • Denmark
      • 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

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Lidocaine 2 ml injection with 2% Adrenaline
Drug: Lidocaine
Placebo Comparator: Isotonic Saline
Isotonic Saline 2 ml Injection
Drug: Isotonic Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous pain on numerical rating scale (NRS 0-10)
Time Frame: 15 minutes after injection
The participant will be asked about spontaneous pain
15 minutes after injection
Evoked pain on numerical rating scale (NRS 0-10)
Time Frame: 15 minutes after injection
15 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brush allodynia
Time Frame: 15 minutes after injection
Assesment of area (cm^2) using a SOMEDIC brush
15 minutes after injection
Pinprick hyperalgesia
Time Frame: 15 minutes after injection
Assesment of area (cm^2) using a von Frey filament (60 g)
15 minutes after injection
Cold allodynia
Time Frame: 15 minutes after injection
Assesment of area (cm^2) using a roll (20 degrees celcius)
15 minutes after injection
Heat allodynia
Time Frame: 15 minutes after injection
Assesment of area (cm^2) using a roll (40 degrees celcius)
15 minutes after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Pain Research Center

Collaborators

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 (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

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

  • Neurom2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Subscribe