NCT02930551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

September 23, 2016

Last Update Submit

February 7, 2019

Conditions

Neuropathic PainNeuroma

Outcome Measures

Primary Outcomes (2)

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

    The participant will be asked about spontaneous pain

    15 minutes after injection

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

    15 minutes after injection

Secondary Outcomes (4)

  • Brush allodynia

    15 minutes after injection

  • Pinprick hyperalgesia

    15 minutes after injection

  • Cold allodynia

    15 minutes after injection

  • Heat allodynia

    15 minutes after injection

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Lidocaine 2 ml injection with 2% Adrenaline

Drug: Lidocaine

Isotonic Saline

PLACEBO COMPARATOR

Isotonic Saline 2 ml Injection

Drug: Isotonic Saline

Interventions

LidocaineDRUG
Lidocaine
Isotonic SalineDRUG
Isotonic Saline

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with peripheral nerve injury 3 months prior to participation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

NeuralgiaNeuroma

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 12, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)