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Neuromas as the Cause of Pain

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ClinicalTrials.gov Identifier: NCT02930551
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Neuroma Drug: Lidocaine Drug: Isotonic Saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
Lidocaine 2 ml injection with 2% Adrenaline
Drug: Lidocaine
Placebo Comparator: Isotonic Saline
Isotonic Saline 2 ml Injection
Drug: Isotonic Saline



Primary Outcome Measures :
  1. Spontaneous pain on numerical rating scale (NRS 0-10) [ Time Frame: 15 minutes after injection ]
    The participant will be asked about spontaneous pain

  2. Evoked pain on numerical rating scale (NRS 0-10) [ Time Frame: 15 minutes after injection ]

Secondary Outcome Measures :
  1. Brush allodynia [ Time Frame: 15 minutes after injection ]
    Assesment of area (cm^2) using a SOMEDIC brush

  2. Pinprick hyperalgesia [ Time Frame: 15 minutes after injection ]
    Assesment of area (cm^2) using a von Frey filament (60 g)

  3. Cold allodynia [ Time Frame: 15 minutes after injection ]
    Assesment of area (cm^2) using a roll (20 degrees celcius)

  4. Heat allodynia [ Time Frame: 15 minutes after injection ]
    Assesment of area (cm^2) using a roll (40 degrees celcius)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930551


Contacts
Contact: Nina S. Buch, MD + 45 78463287 nina.buch@clin.au.dk
Contact: Lone Nikolajsen, MD, DMSc +45 78464317 lone.nikolajsen@clin.au.dk

Locations
Denmark
Danish Pain Research Center, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Nina S. Buch, MD    +45 78463287    nina.buch@clin.au.dk   
Sponsors and Collaborators
Danish Pain Research Center
Aarhus University Hospital

Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT02930551     History of Changes
Other Study ID Numbers: Neurom2016
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neuroma
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action