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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02930551
Other study ID # Neurom2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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