Neuromas as the Cause of Pain

Not Applicable

Completed

• Conditions: Neuropathic Pain; Neuroma
• Interventions: Drug: Lidocaine; Drug: Isotonic Saline

• Registration Number: NCT02930551
• Lead Sponsor: Danish Pain Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	Lidocaine 2 ml injection with 2% Adrenaline
Isotonic Saline	Isotonic Saline	Isotonic Saline 2 ml Injection

Primary Outcome Measures

Name	Time	Method
Spontaneous pain on numerical rating scale (NRS 0-10)	15 minutes after injection	The participant will be asked about spontaneous pain
Evoked pain on numerical rating scale (NRS 0-10)	15 minutes after injection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark