Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities

Summary

The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs. The main questions it aims to answer are: * Is the treatment safe and effective? * Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation? Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.

Eligibility

Inclusion Criteria:

* Are 18 years or older
* Are diagnosed with diabetes type I or II
* Score 3 or above on the Doleur Neuropathique 4 interview section
* Suffer from pain of the lower extremities which

  * is considered by the participant as their dominant overall dominant pain
  * is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days)
  * is present in both feet, roughly symmetrically.
  * has been present for at least 6 months
* Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40.
* Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study
* Are using an approved, safe contraceptive (for premenopausal women)
* Speak, read, and understand Danish

Exclusion Criteria:

* • Have a known allergy or hypersensitivity to BonT-A

  * Have been treated with BonT in the last 6 months.
  * Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  * Have a known malignant condition
  * Have an ongoing infection in the area of injection
  * Are expecting to change their pain medication during the study period
  * Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion
  * Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as:

    * spinal stenosis
    * claudication
    * previous trauma or nerve injury
    * cancer related pain
  * Have a psychiatric condition that affects their completion of the study, as assessed by the investigator.
  * Are active abusers of alcohol or illegal substances
  * Are using or receiving treatment with cannabis products of any kind
  * Are pregnant or planning pregnancy during the study period
  * Score more than 12 on the Charlson Comorbidity Index

Conditions2

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