Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study
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.
• 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