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OpenTrials
Completed

NCT Number: NCT02930551

Neuromas as the Cause of Pain

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.

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Key information

Conditions

Neuropathic Pain Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Neuralgia Neurologic Manifestations Neuroma Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Isotonic saline

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2016
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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