Neuropathic Pain Clinical Trial
Official title:
Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study
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 |
Verified date | February 2019 |
Source | Danish Pain Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Pain Research Center, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Danish Pain Research Center | Aarhus University Hospital |
Denmark,
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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