Neuromas as the Cause of Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930551
• Other study ID #: Neurom2016
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuroma
• Neuropathic Pain

Intervention

Drug:
• Lidocaine

• Isotonic Saline

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous pain on numerical rating scale (NRS 0-10)	The participant will be asked about spontaneous pain	15 minutes after injection
Primary	Evoked pain on numerical rating scale (NRS 0-10)		15 minutes after injection
Secondary	Brush allodynia	Assesment of area (cm^2) using a SOMEDIC brush	15 minutes after injection
Secondary	Pinprick hyperalgesia	Assesment of area (cm^2) using a von Frey filament (60 g)	15 minutes after injection
Secondary	Cold allodynia	Assesment of area (cm^2) using a roll (20 degrees celcius)	15 minutes after injection
Secondary	Heat allodynia	Assesment of area (cm^2) using a roll (40 degrees celcius)	15 minutes after injection