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Neuromas as the Cause of Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02930551
Enrollment
12
Registered
2016-10-12
Start date
2016-09-30
Completion date
2018-12-31
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroma, Neuropathic Pain

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.

Interventions

DRUGLidocaine
DRUGIsotonic Saline

Sponsors

Aarhus University Hospital
CollaboratorOTHER
Danish Pain Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spontaneous pain on numerical rating scale (NRS 0-10)15 minutes after injectionThe participant will be asked about spontaneous pain
Evoked pain on numerical rating scale (NRS 0-10)15 minutes after injection—

Secondary

MeasureTime frameDescription
Brush allodynia15 minutes after injectionAssesment of area (cm\^2) using a SOMEDIC brush
Pinprick hyperalgesia15 minutes after injectionAssesment of area (cm\^2) using a von Frey filament (60 g)
Cold allodynia15 minutes after injectionAssesment of area (cm\^2) using a roll (20 degrees celcius)
Heat allodynia15 minutes after injectionAssesment of area (cm\^2) using a roll (40 degrees celcius)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026