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Neuromas as the Cause of Pain

Primary Purpose

Neuropathic Pain, Neuroma

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Lidocaine

Isotonic Saline

About this trial

This is an interventional diagnostic trial for Neuropathic Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Danish Pain Research Center, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Isotonic Saline

Arm Description

Lidocaine 2 ml injection with 2% Adrenaline

Isotonic Saline 2 ml Injection

Outcomes

Primary Outcome Measures

Spontaneous pain on numerical rating scale (NRS 0-10)

The participant will be asked about spontaneous pain

Evoked pain on numerical rating scale (NRS 0-10)

Secondary Outcome Measures

Brush allodynia

Assesment of area (cm^2) using a SOMEDIC brush

Pinprick hyperalgesia

Assesment of area (cm^2) using a von Frey filament (60 g)

Cold allodynia

Assesment of area (cm^2) using a roll (20 degrees celcius)

Heat allodynia

Assesment of area (cm^2) using a roll (40 degrees celcius)

Full Information

NCT ID

NCT02930551

First Posted

September 23, 2016

Last Updated

February 7, 2019

Sponsor

Danish Pain Research Center

Collaborators

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02930551

Brief Title

Neuromas as the Cause of Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danish Pain Research Center

Collaborators

Aarhus University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Neuroma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

Lidocaine 2 ml injection with 2% Adrenaline

Arm Title

Isotonic Saline

Arm Type

Placebo Comparator

Arm Description

Isotonic Saline 2 ml Injection

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Type

Drug

Intervention Name(s)

Isotonic Saline

Primary Outcome Measure Information:

Title

Spontaneous pain on numerical rating scale (NRS 0-10)

Description

The participant will be asked about spontaneous pain

Time Frame

15 minutes after injection

Title

Evoked pain on numerical rating scale (NRS 0-10)

Time Frame

15 minutes after injection

Secondary Outcome Measure Information:

Title

Brush allodynia

Description

Assesment of area (cm^2) using a SOMEDIC brush

Time Frame

15 minutes after injection

Title

Pinprick hyperalgesia

Description

Assesment of area (cm^2) using a von Frey filament (60 g)

Time Frame

15 minutes after injection

Title

Cold allodynia

Description

Assesment of area (cm^2) using a roll (20 degrees celcius)

Time Frame

15 minutes after injection

Title

Heat allodynia

Description

Assesment of area (cm^2) using a roll (40 degrees celcius)

Time Frame

15 minutes after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Danish Pain Research Center, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

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Neuromas as the Cause of Pain

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